Trial Information

Extended Follow-up of Columbia, MO Serum Bank Participants

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.