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NCT00001163 · ClinicalTrials.gov registry record
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer
A clinical trial of Cancer and Hereditary Neoplasms, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- 5,201
- Enrollment target
- 1
- Study location
NCT00001163: Active study of Cancer and Hereditary Neoplasms, sponsored by National Cancer Institute (NCI).
NCT00001163 is a study of Cancer and Hereditary Neoplasms that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 5,201 participants, above the 3,483-participant average among 615 other Cancer trials with a reported enrollment target (49% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001163, a study of Cancer and Hereditary Neoplasms, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- 5,201 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a clinical, epidemiologic, genetic, and laboratory study of individuals and families at high risk of cancer and selected tumors to investigate the genetic susceptibility and environmental exposures which may alter cancer risk. Families with multiple members who have an unusual pattern or number of cancers or tumors are evaluated clinically. This evaluation is specific for the type of cancer or tumor predominant in the family in order to determine the affection status of each individual for genetic epidemiologic studies. Genetic and environmental risk factor information specific for the tumor type is obtained. Individuals with, or at high risk of, cancer because of their personal, familial, or environmental histories are identified by healthcare worker referral or by personal inquiry. Relevant etiologic risk factor information is documented through review of pathology specimens and medical, vital, and genealogical records. Selected individuals and family members are asked to complete questionnaires and to undergo clinical evaluations specific for the tumor of interest. They are also asked to donate biologic specimens to be used in the search for cancer etiology and mechanisms of carcinogenesis. No therapy beyond counseling and education for cancer prevention, risk reduction, and early detection will be given. Genetic testing for tumor susceptibility gene(s) mutations and risk notification will be offered to study participants for whom a specific mutation predictive of disease has been identified in his/her family. This testing will only be offered 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. Genetic testing and risk notification are entirely optional and do not affect participation in other aspec
Primary Outcome
New cancer development or current health status
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,201 participants |
| Start Date | 1985-04-02 |
What the registry record for NCT00001163 still lists
NCT00001163 is an observational study that tracks outcomes without assigning an intervention. Its 5,201 participants enrollment target places it among the larger protocols in the corpus, above the 3,483-participant average among 615 other Cancer trials with a reported enrollment target (49% higher).
The record links to 4 conditions, with Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT00001163 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001163 about?
NCT00001163 is a clinical study titled "Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer". This is a clinical, epidemiologic, genetic, and laboratory study of individuals and families at high risk of cancer and selected tumors to investigate the genetic susceptibility and environmental exposures which may alter cancer risk. Families with multiple members who have an unusual pattern or num...
What is the current status of trial NCT00001163?
This trial is currently active not recruiting. The enrollment target is 5,201 participants. The study started on 1985-04-02.
What conditions does trial NCT00001163 study?
This clinical trial studies the following conditions: Cancer, Hereditary Neoplasms, Genetic Predisposition to Cancer, Environment.
Who is sponsoring clinical trial NCT00001163?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001163 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001163's enrollment target sits among peer trials
5,201 41st of 615 higher than 575 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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