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Article ; Online: A repeated measures approach to pooled and calibrated biomarker data

Sloan, Abigail / Cheng, Chao / Rosner, Bernard / Ziegler, Regina G. / Smith‐Warner, Stephanie A. / Wang, Molin

Biometrics. 2023 June, v. 79, no. 2 p.1485-1495

2023

Abstract: Participant‐level meta‐analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of ... ...

Abstract	Participant‐level meta‐analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of interest, investigators must first calibrate the data to address measurement variability arising from usage of different laboratories and/or assays. In practice, the calibration process involves reassaying a random subset of biospecimens from each study at a central laboratory and fitting models that relate the study‐specific “local” and central laboratory measurements. Previous work in this area treats the calibration process from the perspective of measurement error techniques and imputes the estimated central laboratory value among individuals with only a local laboratory measurement. In this work, we propose a repeated measures method to calibrate biomarker measurements pooled from multiple studies with study‐specific calibration subsets. We account for correlation between measurements made on the same person and between measurements made at the same laboratory. We demonstrate that the repeated measures approach provides valid inference, and compare it to existing calibration approaches grounded in measurement error techniques in an example describing the association between circulating vitamin D and stroke.
Keywords	biomarkers ; calibration ; meta-analysis ; sample size ; stroke
Language	English
Dates of publication	2023-06
Size	p. 1485-1495.
Publishing place	John Wiley & Sons, Ltd
Document type	Article ; Online
Note	JOURNAL ARTICLE
ZDB-ID	213543-7
ISSN	0099-4987 ; 0006-341X
ISSN	0099-4987 ; 0006-341X
DOI	10.1111/biom.13618
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Article ; Online: A repeated measures approach to pooled and calibrated biomarker data.

Sloan, Abigail / Cheng, Chao / Rosner, Bernard / Ziegler, Regina G / Smith-Warner, Stephanie A / Wang, Molin

Biometrics

2022 Volume 79, Issue 2, Page(s) 1485–1495

Abstract: Participant-level meta-analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of ... ...

Abstract	Participant-level meta-analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of interest, investigators must first calibrate the data to address measurement variability arising from usage of different laboratories and/or assays. In practice, the calibration process involves reassaying a random subset of biospecimens from each study at a central laboratory and fitting models that relate the study-specific "local" and central laboratory measurements. Previous work in this area treats the calibration process from the perspective of measurement error techniques and imputes the estimated central laboratory value among individuals with only a local laboratory measurement. In this work, we propose a repeated measures method to calibrate biomarker measurements pooled from multiple studies with study-specific calibration subsets. We account for correlation between measurements made on the same person and between measurements made at the same laboratory. We demonstrate that the repeated measures approach provides valid inference, and compare it to existing calibration approaches grounded in measurement error techniques in an example describing the association between circulating vitamin D and stroke.
MeSH term(s)	Humans ; Vitamin D ; Research Design ; Biomarkers/analysis ; Sample Size ; Calibration
Chemical Substances	Vitamin D (1406-16-2) ; Biomarkers
Language	English
Publishing date	2022-03-13
Publishing country	United States
Document type	Meta-Analysis ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	213543-7
ISSN	1541-0420 ; 0099-4987 ; 0006-341X
ISSN (online)	1541-0420
ISSN	0099-4987 ; 0006-341X
DOI	10.1111/biom.13618
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Article ; Online: Following up folate and its function in colorectal carcinogenesis.

Ziegler, Regina G

Journal of the National Cancer Institute

2012 Volume 104, Issue 20, Page(s) 1525–1527

MeSH term(s)	Adenoma/epidemiology ; Anticarcinogenic Agents/pharmacology ; Cardiovascular Diseases/prevention & control ; Colorectal Neoplasms/epidemiology ; Female ; Folic Acid/administration & dosage ; Humans ; Male ; Vitamin B 12/administration & dosage ; Vitamin B 6/administration & dosage
Chemical Substances	Anticarcinogenic Agents ; Vitamin B 6 (8059-24-3) ; Folic Acid (935E97BOY8) ; Vitamin B 12 (P6YC3EG204)
Language	English
Publishing date	2012-10-12
Publishing country	United States
Document type	Editorial ; Introductory Journal Article ; Research Support, N.I.H., Intramural ; Comment
ZDB-ID	2992-0
ISSN	1460-2105 ; 0027-8874 ; 0198-0157
ISSN (online)	1460-2105
ISSN	0027-8874 ; 0198-0157
DOI	10.1093/jnci/djs412
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Article ; Online: Statistical methods for biomarker data pooled from multiple nested case-control studies.

Sloan, Abigail / Smith-Warner, Stephanie A / Ziegler, Regina G / Wang, Molin

Biostatistics (Oxford, England)

2019 Volume 22, Issue 3, Page(s) 541–557

Abstract: Pooling biomarker data across multiple studies allows for examination of a wider exposure range than generally possible in individual studies, evaluation of population subgroups and disease subtypes with more statistical power, and more precise ... ...

Abstract	Pooling biomarker data across multiple studies allows for examination of a wider exposure range than generally possible in individual studies, evaluation of population subgroups and disease subtypes with more statistical power, and more precise estimation of biomarker-disease associations. However, circulating biomarker measurements often require calibration to a single reference assay prior to pooling due to assay and laboratory variability across studies. We propose several methods for calibrating and combining biomarker data from nested case-control studies when reference assay data are obtained from a subset of controls in each contributing study. Specifically, we describe a two-stage calibration method and two aggregated calibration methods, named the internalized and full calibration methods, to evaluate the main effect of the biomarker exposure on disease risk and whether that association is modified by a potential covariate. The internalized method uses the reference laboratory measurement in the analysis when available and otherwise uses the estimated value derived from calibration models. The full calibration method uses calibrated biomarker measurements for all subjects, including those with reference laboratory measurements. Under the two-stage method, investigators complete study-specific analyses in the first stage followed by meta-analysis in the second stage. Our results demonstrate that the full calibration method is the preferred aggregated approach to minimize bias in point estimates. We also observe that the two-stage and full calibration methods provide similar effect and variance estimates but that their variance estimates are slightly larger than those from the internalized approach. As an illustrative example, we apply the three methods in a pooling project of nested case-control studies to evaluate (i) the association between circulating vitamin D levels and risk of stroke and (ii) how body mass index modifies the association between circulating vitamin D levels and risk of cardiovascular disease.
MeSH term(s)	Bias ; Biomarkers ; Calibration ; Case-Control Studies ; Humans ; Research Design
Chemical Substances	Biomarkers
Language	English
Publishing date	2019-12-03
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural
ZDB-ID	2031500-4
ISSN	1468-4357 ; 1465-4644
ISSN (online)	1468-4357
ISSN	1465-4644
DOI	10.1093/biostatistics/kxz051
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Article ; Online: Prediagnostic Serum Vitamin D, Vitamin D Binding Protein Isoforms, and Cancer Survival.

Weinstein, Stephanie J / Mondul, Alison M / Layne, Tracy M / Yu, Kai / Huang, Jiaqi / Stolzenberg-Solomon, Rachael Z / Ziegler, Regina G / Purdue, Mark P / Huang, Wen-Yi / Abnet, Christian C / Freedman, Neal D / Albanes, Demetrius

JNCI cancer spectrum

2022 Volume 6, Issue 2

Abstract: Background: Higher circulating vitamin D has been associated with improved overall cancer survival, but data for organ-specific cancers are mixed.: Methods: We examined the association between prediagnostic serum 25-hydroxyvitamin D [25(OH)D], the ... ...

Abstract	Background: Higher circulating vitamin D has been associated with improved overall cancer survival, but data for organ-specific cancers are mixed. Methods: We examined the association between prediagnostic serum 25-hydroxyvitamin D [25(OH)D], the recognized biomarker of vitamin D status, and cancer survival in 4038 men and women diagnosed with 1 of 11 malignancies during 22 years of follow-up (median = 15.6 years) within the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Multivariable-adjusted proportional hazards regression estimated hazard ratios (HR) and 95% confidence intervals (CI) for associations between baseline 25(OH)D concentration and subsequent cancer survival; we also stratified on the common vitamin D binding protein isoforms (Gc1f, Gc1s, and Gc2) defined by two single-nucleotide polymorphisms (rs7041 and rs4588) in the vitamin D binding protein gene GC. All P values were 2-sided. Results: Higher 25(OH)D concentrations were associated with greater overall cancer survival (HR for cancer mortality = 0.83, 95% CI = 0.70 to 0.98 for highest vs lowest quintile; Ptrend = .05) and lung cancer survival (HR = 0.63, 95% CI = 0.44 to 0.90; Ptrend = .03). These associations were limited to cases expressing the Gc2 isoform (HR = 0.38 for Gc2-2, 95% CI = 0.14 to 1.05 for highest vs lowest quintile; Ptrend = .02; and HR = 0.30 for Gc1-2/Gc2-2 combined, 95% CI = 0.16 to 0.56; Ptrend < .001 for overall and lung cancer, respectively). Conclusions: Higher circulating 25(OH)D was associated with improved overall and lung cancer survival. As this was especially evident among cases with the genetically determined Gc2 isoform of vitamin D binding protein, such individuals may gain a cancer survival advantage by maintaining higher 25(OH)D blood concentrations.
MeSH term(s)	Female ; Humans ; Lung Neoplasms/genetics ; Male ; Polymorphism, Single Nucleotide ; Protein Isoforms/genetics ; Vitamin D ; Vitamin D-Binding Protein/genetics
Chemical Substances	Protein Isoforms ; Vitamin D-Binding Protein ; Vitamin D (1406-16-2)
Language	English
Publishing date	2022-05-22
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Intramural
ISSN	2515-5091
ISSN (online)	2515-5091
DOI	10.1093/jncics/pkac019
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Article ; Online: Workshop on measuring estrogen exposure and metabolism: Summary of the presentations.

Santen, Richard J / Demers, Laurence M / Ziegler, Regina G

Steroids

2015 Volume 99, Issue Pt A, Page(s) 1–7

MeSH term(s)	Adolescent ; Androgens/physiology ; Aromatase Inhibitors/therapeutic use ; Bone and Bones/physiology ; Breast Neoplasms/drug therapy ; Breast Neoplasms/metabolism ; Chemistry, Clinical/methods ; Chromatography, Liquid/methods ; Congresses as Topic ; Estradiol/analysis ; Estrogens/analysis ; Estrogens/metabolism ; Estrogens/physiology ; Female ; Humans ; Male ; Mass Spectrometry/methods ; Postmenopause ; Steroids/analysis ; Young Adult
Chemical Substances	Androgens ; Aromatase Inhibitors ; Estrogens ; Steroids ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2015-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	80312-1
ISSN	1878-5867 ; 0039-128X
ISSN (online)	1878-5867
ISSN	0039-128X
DOI	10.1016/j.steroids.2014.12.012
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Article: Phytoestrogens and breast cancer.

Ziegler, Regina G

The American journal of clinical nutrition

2004 Volume 79, Issue 2, Page(s) 183–184

MeSH term(s)	Aged ; Breast Neoplasms/epidemiology ; Breast Neoplasms/prevention & control ; Diet ; Female ; Humans ; Isoflavones/classification ; Isoflavones/metabolism ; Isoflavones/therapeutic use ; Middle Aged ; Netherlands/epidemiology ; Phytoestrogens ; Plant Preparations/classification ; Plant Preparations/metabolism ; Plant Preparations/therapeutic use ; Receptors, Estrogen/metabolism
Chemical Substances	Isoflavones ; Phytoestrogens ; Plant Preparations ; Receptors, Estrogen
Language	English
Publishing date	2004-02
Publishing country	United States
Document type	Comment ; Editorial
ZDB-ID	280048-2
ISSN	1938-3207 ; 0002-9165
ISSN (online)	1938-3207
ISSN	0002-9165
DOI	10.1093/ajcn/79.2.183
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Article ; Online: Epidemiologic studies of estrogen metabolism and breast cancer.

Ziegler, Regina G / Fuhrman, Barbara J / Moore, Steven C / Matthews, Charles E

Steroids

2015 Volume 99, Issue Pt A, Page(s) 67–75

Abstract: Early epidemiologic studies of estrogen metabolism measured only 2-hydroxyestrone and 16α-hydroxyestrone and relied on direct enzyme immunoassays without purification steps. Eight breast cancer studies have used these assays with prospectively collected ... ...

Abstract	Early epidemiologic studies of estrogen metabolism measured only 2-hydroxyestrone and 16α-hydroxyestrone and relied on direct enzyme immunoassays without purification steps. Eight breast cancer studies have used these assays with prospectively collected blood or urine samples. Results were inconsistent, and generally not statistically significant; but the assays had limited specificity, especially at the low concentrations characteristic of postmenopausal women. To facilitate continued testing in population-based studies of the multiple laboratory-based hypotheses about the roles of estrogen metabolites, a novel liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay was developed to measure concurrently all 15 estrogens and estrogen metabolites in human serum and urine, as unconjugated and total (glucuronidated+sulfated+unconjugated) concentrations. The assay has high sensitivity (lower limit of quantitation ∼1-2 pmol/L), reproducibility (coefficients of variation generally ⩽5%), and accuracy. Three prospective studies utilizing this comprehensive assay have demonstrated that enhanced 2-hydroxylation of parent estrogens (estrone+estradiol) is associated with reduced risk of postmenopausal breast cancer. In the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) cohort, the serum ratio of 2-hydroxylation pathway metabolites to parent estrogens was associated with a 28% reduction in breast cancer risk across extreme deciles (p-trend=.05), after adjusting for unconjugated estradiol and breast cancer risk factors. Incorporating this ratio into a risk prediction model already including unconjugated estradiol improved absolute risk estimates substantially (by ⩾14%) in 36% of the women, an encouraging result that needs replication. Additional epidemiologic studies of the role of estrogen metabolism in the etiology of hormone-related diseases and continued improvement of estrogen metabolism assays are justified.
MeSH term(s)	Breast Neoplasms/epidemiology ; Breast Neoplasms/metabolism ; Chromatography, Liquid ; Epidemiologic Studies ; Estrogens/analysis ; Estrogens/metabolism ; Female ; Humans ; Hydroxyestrones/metabolism ; Postmenopause ; Premenopause ; Prospective Studies ; Risk Factors ; Tandem Mass Spectrometry/methods
Chemical Substances	Estrogens ; Hydroxyestrones ; 16-hydroxyestrone (18186-49-7) ; 2-hydroxyestrone (UQS3A06ILY)
Language	English
Publishing date	2015-02-26
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	80312-1
ISSN	1878-5867 ; 0039-128X
ISSN (online)	1878-5867
ISSN	0039-128X
DOI	10.1016/j.steroids.2015.02.015
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Article: Dietary Fiber Intake and Risk of Advanced and Aggressive Forms of Prostate Cancer: A Pooled Analysis of 15 Prospective Cohort Studies.

Sidahmed, Elkhansa / Freedland, Stephen J / Wang, Molin / Wu, Kana / Albanes, Demetrius / Barnett, Matt / van den Brandt, Piet A / Cook, Michael B / Giles, Graham G / Giovannucci, Edward / Haiman, Christopher A / Larsson, Susanna C / Key, Timothy J / Loftfield, Erikka / Männistö, Satu / McCullough, Marjorie L / Milne, Roger L / Neuhouser, Marian L / Platz, Elizabeth A /

Perez-Cornago, Aurora / Sawada, Norie / Schenk, Jeannette M / Sinha, Rashmi / Tsugane, Shoichiro / Visvanathan, Kala / Wang, Ying / White, Kami K / Willett, Walter C / Wolk, Alicja / Ziegler, Regina G / Genkinger, Jeanine M / Smith-Warner, Stephanie A

Journal of the Academy of Nutrition and Dietetics

2024

Abstract: Background: Evidence of an association between dietary fiber intake and risk of advanced and aggressive forms of prostate cancer (PC) and PC mortality is limited.: Objective: To examine associations between intakes of dietary fiber overall and by ... ...

Abstract	Background: Evidence of an association between dietary fiber intake and risk of advanced and aggressive forms of prostate cancer (PC) and PC mortality is limited. Objective: To examine associations between intakes of dietary fiber overall and by food source and risk of advanced and aggressive forms of PC. Design: Pooled analysis of the primary data in 15 cohorts in three continents. Baseline dietary fiber intake was assessed using a validated food frequency questionnaire or diet history in each study. Participants/setting: 842,149 men were followed for up to 9-22 years between 1985-2009 across studies. Main outcome measures: The primary outcome measures were advanced (stage T4, N1, or M1 or PC mortality), advanced restricted (excluded men with missing stage and those with localized PC who died of PC), high grade (Gleason score ≥8 or poorly differentiated/undifferentiated) PC, and PC mortality. Statistical analysis: Study-specific multivariable hazard ratios (MVHR) were calculated using Cox proportional hazards regression and pooled using random effects models. Results: Intake of dietary fiber overall, from fruits, and from vegetables was not associated with risk of advanced (n=4,863), advanced restricted (n=2,978), or high-grade PC (n=9,673) or PC mortality (n=3,097). Dietary fiber intake from grains was inversely associated with advanced PC (MVHR comparing the highest vs. lowest quintile=0.84, 95% confidence interval [CI] 0.76-0.93), advanced restricted PC (MVHR=0.85, 95%CI 0.74-0.97), and PC mortality (MVHR=0.78, 95%CI 0.68-0.89); statistically significant trends were noted for each of these associations (p≤0.03), while a null association was observed for high grade PC for the same comparison (MVHR=1.00, 95%CI 0.93-1.07). The comparable results were 1.06 (95%CI 1.01-1.10, p-value, test for trend=0.002) for localized (n=35,199) and 1.05 (95%CI 0.99-1.11, , p-value, test for trend=0.04) for low/intermediate grade (n=34,366) PC. Conclusions: Weak nonsignificant associations were observed between total dietary fiber intake and risk of advanced forms of PC, high grade PC, and PC mortality. High dietary fiber intake from grains was associated with a modestly lower risk of advanced forms of PC and PC mortality.
Language	English
Publishing date	2024-04-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	2646718-5
ISSN	2212-2672
ISSN	2212-2672
DOI	10.1016/j.jand.2024.04.006
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Article ; Online: Prediagnostic White Blood Cell DNA Methylation and Risk of Breast Cancer in the Prostate Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) Cohort.

Sturgeon, Susan R / Sela, David A / Browne, Eva P / Einson, Jonah / Rani, Asha / Halabi, Mohamed / Kania, Thomas / Keezer, Andrew / Balasubramanian, Raji / Ziegler, Regina G / Schairer, Catherine / Kelsey, Karl T / Arcaro, Kathleen F

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology

2021 Volume 30, Issue 8, Page(s) 1575–1581

Abstract: Background: White blood cell (WBC) DNA may contain methylation patterns that are associated with subsequent breast cancer risk. Using a high-throughput array and samples collected, on average, 1.3 years prior to diagnosis, a case-cohort analysis nested ... ...

Abstract	Background: White blood cell (WBC) DNA may contain methylation patterns that are associated with subsequent breast cancer risk. Using a high-throughput array and samples collected, on average, 1.3 years prior to diagnosis, a case-cohort analysis nested in the prospective Sister Study identified 250 individual CpG sites that were differentially methylated between breast cancer cases and noncases. We examined five of the top 40 CpG sites in a case-control study nested in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) Cohort. Methods: We investigated the associations between prediagnostic WBC DNA methylation in 297 breast cancer cases and 297 frequency-matched controls. Two WBC DNA specimens from each participant were used: a proximate sample collected 1 to 2.9 years and a distant sample collected 4.2-7.3 years prior to diagnosis in cases or the comparable timepoints in controls. WBC DNA methylation level was measured using targeted bisulfite amplification sequencing. We used logistic regression to obtain ORs and 95% confidence intervals (CI). Results: A one-unit increase in percent methylation in Conclusions: There was no convincing pattern between percent methylation in the five CpG sites and breast cancer risk. Impact: The link between prediagnostic WBC DNA methylation marks and breast cancer, if any, is poorly understood.
MeSH term(s)	Aged ; Breast Neoplasms/genetics ; Case-Control Studies ; Cell Cycle Proteins/genetics ; CpG Islands ; DNA Methylation ; DNA-Binding Proteins/genetics ; Endonucleases/genetics ; Female ; Humans ; Intracellular Signaling Peptides and Proteins/genetics ; Leukocytes ; Membrane Proteins/genetics ; Membrane Transport Proteins/genetics ; Middle Aged ; Mitochondrial Proteins/genetics ; Prospective Studies
Chemical Substances	CAVIN3 protein, human ; Cell Cycle Proteins ; DNA-Binding Proteins ; Intracellular Signaling Peptides and Proteins ; MCUR1 protein, human ; Membrane Proteins ; Membrane Transport Proteins ; Mitochondrial Proteins ; OPTN protein, human ; ERCC1 protein, human (EC 3.1.-) ; Endonucleases (EC 3.1.-)
Language	English
Publishing date	2021-06-09
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Intramural
ZDB-ID	1153420-5
ISSN	1538-7755 ; 1055-9965
ISSN (online)	1538-7755
ISSN	1055-9965
DOI	10.1158/1055-9965.EPI-20-1717
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