Clinical trial NCT00340210: Extended Follow-up of Columbia, MO Serum Bank Participants
Official title: Extended Follow-up of Columbia, MO Serum Bank Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Endometrial Cancer
Ovarian Cancer
Keywords: Biomarkers
Breast Cancer
Etiology
Hormones
Prospective Study
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 6720
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: 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.

Eligibility criteria: * Not listed.

Primary outcomes:
measure: Primary Cancer diagnosis
timeFrame: time of diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI), 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Gretchen Benson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Dorgan 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.
citation: Falk 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.