Extended Follow-up of Columbia, MO Serum Bank Participants
Condition: Breast Cancer; Endometrial Cancer; Ovarian Cancer
MeSH terms: Endometrial Neoplasms
Study type: Observational

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.
    

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.
      
Keywords: Biomarkers; Breast Cancer; Etiology; Hormones; Prospective Study