Brief Title
Extended Follow-up of Columbia, MO Serum Bank Participants
Official Title
Extended Follow-up of Columbia, MO Serum Bank Participants
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.
Study Type
Observational
Primary Outcome
Primary Cancer diagnosis
Condition
Breast Cancer
Study Arms / Comparison Groups
Serum Bank Participants
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
6720
Start Date
January 14, 1999
Completion Date
September 2, 2014
Primary Completion Date
June 24, 2014
Eligibility Criteria
- Not listed.
Gender
Female
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Gretchen Benson, Ph.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00340210
Organization ID
999999002
Secondary IDs
OH99-C-N002
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Gretchen Benson, Ph.D., Principal Investigator, National Cancer Institute (NCI)
Verification Date
September 2020