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NCT00340210 · ClinicalTrials.gov registry record
Extended Follow-up of Columbia, MO Serum Bank Participants
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 6,720
- Enrollment target
NCT00340210: Completed study, sponsored by National Cancer Institute (NCI).
NCT00340210 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 6,720 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00340210 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 6,720 participants
- Enrollment target
Study 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 exte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,720 participants |
| Start Date | 1999-01-14 |
| Est. Completion | 2014-09-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00340210
The ClinicalTrials.gov registry entry for NCT00340210 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6,720 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00340210 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00340210 about?
NCT00340210 is a clinical study titled "Extended Follow-up of Columbia, MO Serum Bank Participants". 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 Univ...
What is the current status of trial NCT00340210?
This trial is currently completed. The enrollment target is 6,720 participants. The study started on 1999-01-14. Estimated completion is 2014-09-02.
Who is sponsoring clinical trial NCT00340210?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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