Extended Follow-up of Columbia, MO Serum Bank Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340210
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

The purpose of this investigation is to extend follow-up to ascertain cancer diagnoses and deaths through the present time among women who donated serum to the Columbia, MO serum bank. All breast cancers will be confirmed by medical records or cancer registries, and tissue blocks will be obtained for some breast tumors. Informed consent will be obtained for analysis of biomarkers in serum and pathology specimens.

The Columbia, MO serum bank was established as part of the National Cancer Institute's Biological Markers Project to identify serum markers for breast cancer. A total of 6,915 women living in and around Columbia, MO who were free of cancer, other than non-melanoma skin cancer, donated blood to the serum bank on more than one occasions between 1977 and 1987. Women were followed until 1989; however, 79% were last contacted in 1983 or earlier. When contacted last, 95% of the women were alive.

At the time of each blood collection, information was obtained from participants on the major known breast cancer risk factors, including age, height, weight, reproductive and menstrual histories, and family history of breast cancer. Medical conditions and drug use, including oral contraceptives and hormone replacement therapy, also were ascertained. Serum has been stored at -70 degrees C since it was collected. Of the 6,915 women who were free of cancer when they donated blood to the serum bank 6,720 (97%) have at least one vial of serum remaining in the bank. For the majority of women, the serum is from a single collection, although 30% have vials remaining from two collections that averaged a year apart. An average of ten 1.1 ml. visits remain for each women at each collection.

During the original follow-up of Columbia, MO serum bank participants (until 1889), 244 invasive cancers, including 107 breast cancers, were ascertained among women who were cancer-free at blood collection and who have serum remaining in the serum bank. Based on SEER incidence rates, we project that the proposed extended follow-up of these women will identify 869 additional invasive cancers, including 283 additional breast cancers. Furthermore, we anticipate that 128 lung cancers and 113 colorectal cancers will be identified, which in addition to cancers previously identified, will yield a total of 144 cancers at each of these sites.

At the end of the project, we will have serum samples from a cohort of 6,720 healthy women followed for up to 20 years for cancer diagnoses. This will provide a unique resource for the Division that can be used for biochemical epidemiology studies aimed at identifying serum markers associated with cancer risk.


Condition
Cancer
Morbidity

Study Type: Observational
Official Title: Extended Follow-up of Columbia, MO Serum Bank Participants

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 6720
Study Start Date: December 1998
Detailed Description:

The purpose of this investigation is to extend follow-up to ascertain cancer diagnoses and deaths through the present time among women who donated serum to the Columbia, MO serum bank. All breast cancers will be confirmed by medical records or cancer registries, and tissue blocks will be obtained for some breast tumors. Informed consent will be obtained for analysis of biomarkers in serum and pathology specimens.

The Columbia, MO serum bank was established as part of the National Cancer Institute's Biological Markers Project to identify serum markers for breast cancer. A total of 6,915 women living in and around Columbia, MO who were free of cancer, other than non-melanoma skin cancer, donated blood to the serum bank on more than one occasions between 1977 and 1987. Women were followed until 1989; however, 79% were last contacted in 1983 or earlier. When contacted last, 95% of the women were alive.

At the time of each blood collection, information was obtained from participants on the major known breast cancer risk factors, including age, height, weight, reproductive and menstrual histories, and family history of breast cancer. Medical conditions and drug use, including oral contraceptives and hormone replacement therapy, also were ascertained. Serum has been stored at -70 degrees C since it was collected. Of the 6,915 women who were free of cancer when they donated blood to the serum bank 6,720 (97%) have at least one vial of serum remaining in the bank. For the majority of women, the serum is from a single collection, although 30% have vials remaining from two collections that averaged a year apart. An average of ten 1.1 ml. visits remain for each women at each collection.

During the original follow-up of Columbia, MO serum bank participants (until 1989), 244 invasive cancers, including 107 breast cancers, were ascertained among women who were cancer-free at blood collection and who have serum remaining in the serum bank. Our latest follow-up has identified a total of 1123 additional cancers. A total of 351 of these were breast cancers, with 304 of them having been medically confirmed and 47 being based on self reports.

At the end of the project, we will have serum samples from a cohort of 6,720 healthy women followed for up to 20 years for cancer diagnoses. This will provide a unique resource for the Division that can be used for biochemical epidemiology studies aimed at identifying serum markers associated with cancer risk.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Not listed.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00340210

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Louise Brinton, Ph.D. National Cancer Institute (NCI)