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NCT03953443 · ClinicalTrials.gov registry record
Expression & Epigenetic Silencing of MicroRNA for Predicting Therapeutic Response and Prognosis of HPV-negative HNSCC
A clinical trial, sponsored by New Mexico Cancer Research Alliance.
- Completed
- Registry status
- 25
- Enrollment target
NCT03953443: Completed study, sponsored by New Mexico Cancer Research Alliance.
NCT03953443 is a clinical trial that has completed, run by New Mexico Cancer Research Alliance. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03953443 has completed, sponsored by New Mexico Cancer Research Alliance.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
A two-part molecular epidemiological study will be conducted to comprehensively assess the association between miR expression and miR promoter methylation and the response to therapy and prognosis in primary, HPV-negative HNSCC patients. Part 1 will be a prospective collection of 25 pairs of fresh tumor-distant normal mucosal tissue in patients with HNSCC. Ultimately, 15 HPV-negative tumor-mucosal pairs will be utilized for discovery work in identifying miRs whose expression is up- or down-regulated in tumors. Part 2 will test the association between miR expression and miR promoter methylation, and therapeutic response and survival in all archived surgical cases of HPV-negative HNSCC at University of New Mexico Hospital (UNMH) collected after 1990.
Primary Outcome
SOLiD sequencing of fresh tumor-distant normal pairs will discover miRs whose expression is altered in HNSCC tumors. SOLiD sequencing will provide fully quantitative data for the expression of known and novel miRs. Because HPV-related tumors comprise approximately 20% of all HNSCC and are biologically distinct from HPV negative tumors classically associated with tobacco and alcohol, only HNSCC without p16 overexpression will be used in this discovery experiment. This restriction will increase ho
Interventions
- OTHER Not interventional
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-12-17 |
| Est. Completion | 2023-03-14 |
What the finished NCT03953443 record still lists
NCT03953443 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Not interventional is the first listed.
NCT03953443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03953443 about?
NCT03953443 is a clinical study titled "Expression & Epigenetic Silencing of MicroRNA for Predicting Therapeutic Response and Prognosis of HPV-negative HNSCC". A two-part molecular epidemiological study will be conducted to comprehensively assess the association between miR expression and miR promoter methylation and the response to therapy and prognosis in primary, HPV-negative HNSCC patients. Part 1 will be a prospective collection of 25 pairs of fresh t...
What is the current status of trial NCT03953443?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2010-12-17. Estimated completion is 2023-03-14.
What interventions are being tested in trial NCT03953443?
The interventions under investigation include: Not interventional (OTHER).
Who is sponsoring clinical trial NCT03953443?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
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