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NCT00040222 · ClinicalTrials.gov registry record
Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 377
- Enrollment target
NCT00040222: Completed study, sponsored by National Cancer Institute (NCI).
NCT00040222 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 377 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00040222 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 377 participants
- Enrollment target
Study Summary
Individuals and families with known or suspected syndromes that include breast, ovarian or genetically-related cancers are enrolled in this family study, which is a syndrome-specific sub-set of the long-standing DCEG Human Genetics Program umbrella family studies protocol (78-C-0039). Cancer outcomes are documented through review of medical, vital, and pathology records. Selected individuals and family members are asked to complete questionnaires to assess etiologic risk factors and to undergo clinical evaluations specifically tailored to the relevant familial syndrome. Study participants are monitored prospectively for the development of outcomes of interest, typically by means of periodic mail or telephone contact. In selected instances, subjects may return to the Clinical Center periodically for study-specific follow-up examinations. Study participants are asked to donate biologic specimens to be used in the laboratory search for cancer etiology and mechanisms of carcinogenesis. DNA and serial serum samples will be collected. Tumor tissue will be obtained whenever feasible. Clinical genetic testing for tumor susceptibility gene(s) mutations and risk notification will be offered consistent with ASCO guidelines when reasonable individual cancer risk estimates can be delivered, and only to those participants who choose to know their individual genetic status after appropriate education and counseling. The testing will be conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratories. Clinical genetic testing and risk notification are entirely optional and do not affect subject eligibility for other aspects of the protocol. A separate consent procedure and consent form will be used for genetic testing and risk notification. This protocol, developed in response to recommendations developed by the Clinical Center IRB, is intended to: 1. Provide a mechanism under which the Clinical Genetics Branch can honor the commitment made to the
Primary Outcome
To ascertain individuals and families at high risk of breast, ovarian andother syndromically related cancers due to known or suspected genetic factor(s) which predispose to neoplasia in order to:- Evaluate and define the clinical spectrum and natural history of disease in syndromes predisposing to familial breast/ovarian cancer;- Develop a resource of epidemiologic, clinical, behavioral and genetic information on individuals and families predisposed to familial breast/ovarian cancer; - Track and
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2002-07-01 |
What the finished NCT00040222 record still lists
NCT00040222 is an observational study that tracks outcomes without assigning an intervention. The registered 377 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00040222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00040222 about?
NCT00040222 is a clinical study titled "Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer". Individuals and families with known or suspected syndromes that include breast, ovarian or genetically-related cancers are enrolled in this family study, which is a syndrome-specific sub-set of the long-standing DCEG Human Genetics Program umbrella family studies protocol (78-C-0039). Cancer outcome...
What is the current status of trial NCT00040222?
This trial is currently completed. The enrollment target is 377 participants. The study started on 2002-07-01.
Who is sponsoring clinical trial NCT00040222?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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