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NCT01200680 · ClinicalTrials.gov registry record
Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-Susceptibility Genes
A clinical trial of Genes and Sporadic Chordoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- 188
- Enrollment target
- 1
- Study location
NCT01200680: Active study of Genes and Sporadic Chordoma, sponsored by National Cancer Institute (NCI).
NCT01200680 is a study of Genes and Sporadic Chordoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 188 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01200680, a study of Genes and Sporadic Chordoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- 188 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Chordoma is a rare, slow growing, often fatal bone cancer derived from remnants of the embryonic notochord. It occurs mostly in the axial skeleton (skull base, vertebrae, sacrum and coccyx), is more frequent in males than females, and has a median age at diagnosis of 58.5 years, with a wide age range. This typically sporadic tumor is often advanced at presentation, and mortality is high due to local recurrence or distant metastases. The usual treatment is surgery, followed by adjuvant radiation therapy. Chemotherapy has not had a significant treatment role. Reports of a small number of families worldwide with two or more relatives with chordoma support a role for susceptibility genes in chordoma etiology. Recently we determined that duplications of the T gene co-segregated with disease in four multiplex chordoma families. The T gene encodes brachyury, a tissue-specific transcription factor that is expressed in notochord cells and is essential for formation and maintenance of the notochord. Some of the other chordoma families that we studied did not have T-gene duplications; the aggregation of chordomas in these families may result from changes in other susceptibility genes or other types of mutations targeting the T gene. We are continuing gene identification studies of multiplex chordoma families at the NIH Clinical Center under protocol 78-C-0039. We also want to determine whether alterations in any identified chordoma susceptibility genes are associated with sporadic chordoma in the general population. Objectives: The major goal of this protocol is to identify sporadic chordoma patients willing to provide germline and tumor DNA for studies to determine the frequency of alterations in chordoma susceptibility genes. Our previous protocols with SEER and Massachusetts General Hospital to identify chordoma patients were limited to residents of specific geographic regions in the U.S. (2 states and 2 metropolitan areas) or to patients with pediatric skull
Primary Outcome
\- Susceptibility genes for Chordoma - Association between age at dx/Chordoma subtype and genetic risk factors
Conditions Studied
Study Locations (1)
Maryland
- Westat, Inc. - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2011-01-02 |
What the registry record for NCT01200680 still lists
NCT01200680 is an observational study that tracks outcomes without assigning an intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Genes appearing as the primary indexed condition, and to 0 interventions.
NCT01200680 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01200680 about?
NCT01200680 is a clinical study titled "Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-Susceptibility Genes". Background: Chordoma is a rare, slow growing, often fatal bone cancer derived from remnants of the embryonic notochord. It occurs mostly in the axial skeleton (skull base, vertebrae, sacrum and coccyx), is more frequent in males than females, and has a median age at diagnosis of 58.5 years, with a ...
What is the current status of trial NCT01200680?
This trial is currently active not recruiting. The enrollment target is 188 participants. The study started on 2011-01-02.
What conditions does trial NCT01200680 study?
This clinical trial studies the following conditions: Genes, Sporadic Chordoma.
Who is sponsoring clinical trial NCT01200680?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01200680 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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