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NCT02289326 · ClinicalTrials.gov registry record
Biomarker Monitoring in TP53 Mutation Carriers
A clinical trial, sponsored by Scripps Health.
- Completed
- Registry status
- 6
- Enrollment target
NCT02289326 is a clinical trial that has completed, run by Scripps Health. The registered enrollment target is 6 participants.
The verdict
NCT02289326 has completed, sponsored by Scripps Health.
- COMPLETED
- Registry status
- 6 participants
- Enrollment target
Study Summary
Purpose This study is an 'N-of-one' observational study focusing on individuals with a hereditary predisposition to cancer due to a genetic mutation in the TP53 gene. An individual with this mutation has a \>90% chance of developing many different forms of cancer in their lifetime. Since germline TP53 gene mutation carriers are highly susceptible to cancer, cancer prevention strategies and early cancer detection strategies are crucial. Unfortunately, the current standard of care for monitoring germline TP53 gene mutation carriers for early signs of cancer is yearly MRI scans and intermittent blood draws. Villani et al. showed that standard monitoring is inadequate and introduced a more sophisticated protocol for early cancer detection. We extended the Villani et al. protocol to include a number of markers for early detection and are currently vetting their utility, in terms of their inherent variability, patient tolerability of frequent interrogation, and ability to show changes that might indicate a need for further examination. In addition to the markers being collected, important covariate information, such as diet, sleep, and activities are being collected (via, e.g., wearable wireless devices) in order to take them into account in assessing the levels of the markers at a single data collection time or over time. One important aspect of the protocol is to identify changes, rather than specific levels, in marker status over time for an individual that might be indicative of tumor formation, essentially exploiting the concept of 'personalized thresholds' discussed by Drescher et al. If any indication of the presence of a cancer, tumorigenic process, or general sign of ill-health is observed, the protocol calls for a discussion of the findings among the research team, followed by a discussion between the clinical lead on the research team and the primary care provider and/or specialists overseeing a participating patient's care, possible validation of the assay(
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02289326
The ClinicalTrials.gov registry entry for NCT02289326 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scripps Health, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02289326 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02289326 about?
NCT02289326 is a clinical study titled "Biomarker Monitoring in TP53 Mutation Carriers". Purpose This study is an 'N-of-one' observational study focusing on individuals with a hereditary predisposition to cancer due to a genetic mutation in the TP53 gene. An individual with this mutation has a \>90% chance of developing many different forms of cancer in their lifetime. Since germline T...
What is the current status of trial NCT02289326?
This trial is currently completed. The enrollment target is 6 participants. The study started on 2014-07. Estimated completion is 2016-07.
Who is sponsoring clinical trial NCT02289326?
This trial is sponsored by Scripps Health, which has 30 total clinical trials registered on ClinicalTrials.gov.
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