Extended Follow-up of Columbia, MO Serum Bank Participants
2 other identifiers
observational
6,720
1 country
1
Brief Summary
The Columbia, MO Serum Bank initially was established in 1977 as part of the National Cancer Institute's (NCI) Biological Markers Project to identify serum markers for breast cancer. Participants were volunteers identified through the Breast Cancer Detection Demonstration Project (BCDDP) at the University of Missouri Hospital and Ellis Fischel Cancer Center in Columbia, MO. A total of 6,915 women without a prior history of cancer, other than non-melanoma skin cancer, donated blood to the bank on one or more occasions between 1977 and 1987. At the time of each blood collection, interview information was obtained including age, height, weight, reproductive and menstrual histories, family history of breast cancer, medical conditions, and drug use, including oral contraceptives and menopausal hormone therapy. Date of last menstrual period was captured for women who were premenopausal at the time of each blood collection. Approximately 30% of the women donated multiple samples over the first 10 years of the study, (including 20% with 3 or more samples), with collections occurring on average one year apart. At each collection, serum was aliquoted into up to ten, 1 ml vials and stored at -70 (Infinite)C at the NCI Repository. All women gave informed consent before donating to the serum bank. The initial follow-up continued for up to 12 years through 1989, with 244 cancers identified. Of the 6915 original participants, 79% were last seen in 1983 or earlier, yielding a median follow-up time of 4 years. A questionnaire was mailed to all participants annually to ascertain information on interim breast biopsies and cancer diagnoses. Women who indicated that they had a breast biopsy or breast cancer were sent a consent form for permission to obtain medical records including pathology reports. For cancers at sites other than the breast, medical records and pathology reports were not requested, although date of diagnosis and site were ascertained. Between 1999 and 2002, an extended follow-up of Columbia, MO Serum Bank participants was conducted. Of the 6915 original participants, 6,720 women had blood remaining and were included in this phase of the study. Of these, 6,154 (91.6%) were located; 566 (8%) were not locatable, 109 (2%) refused to participate, and 40 (\<1%) were too ill to participate. 1,694 women (25%) were deceased. This last follow-up identified an additional 1123 cancers. This cohort has serum samples from a cohort of 6720 pre- and postmenopausal women followed up to 20 years for cancer diagnoses and is a unique resource for molecular epidemiologic studies exploring serum markers associated with cancer risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 1999
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 1999
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2014
CompletedSeptember 10, 2020
September 1, 2020
15.5 years
June 19, 2006
September 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Cancer diagnosis
Primary Cancer diagnosis
time of diagnosis
Study Arms (1)
Serum Bank Participants
The Columbia MO Serum Bank recruited 6915 women living in and around Columbia MO between 1977-1987 who were cancer-free except for non-melanoma skin cancer and at least 18 years of age.
Eligibility Criteria
The Columbia MO Serum Bank recruited 6915 women living in and around Columbia MO between 1977- 1987 who were cancer-free except for non-melanoma skin cancer and at least 18 years of age.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Dorgan JF, Longcope C, Stephenson HE Jr, Falk RT, Miller R, Franz C, Kahle L, Campbell WS, Tangrea JA, Schatzkin A. Relation of prediagnostic serum estrogen and androgen levels to breast cancer risk. Cancer Epidemiol Biomarkers Prev. 1996 Jul;5(7):533-9.
PMID: 8827358BACKGROUNDDorgan JF, Stanczyk FZ, Longcope C, Stephenson HE Jr, Chang L, Miller R, Franz C, Falk RT, Kahle L. Relationship of serum dehydroepiandrosterone (DHEA), DHEA sulfate, and 5-androstene-3 beta, 17 beta-diol to risk of breast cancer in postmenopausal women. Cancer Epidemiol Biomarkers Prev. 1997 Mar;6(3):177-81.
PMID: 9138660BACKGROUNDFalk RT, Dorgan JF, Kahle L, Potischman N, Longcope C. Assay reproducibility of hormone measurements in postmenopausal women. Cancer Epidemiol Biomarkers Prev. 1997 Jun;6(6):429-32.
PMID: 9184776BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gretchen Benson, Ph.D.
National Cancer Institute (NCI)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
January 14, 1999
Primary Completion
June 24, 2014
Study Completion
September 2, 2014
Last Updated
September 10, 2020
Record last verified: 2020-09