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NCT03951389 · ClinicalTrials.gov registry record
INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer
A clinical trial, sponsored by New Mexico Cancer Research Alliance.
- Completed
- Registry status
- 750
- Enrollment target
NCT03951389: Completed study, sponsored by New Mexico Cancer Research Alliance.
NCT03951389 is a clinical trial that has completed, run by New Mexico Cancer Research Alliance. The registered enrollment target is 750 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03951389 has completed, sponsored by New Mexico Cancer Research Alliance.
- COMPLETED
- Registry status
- 750 participants
- Enrollment target
Study Summary
This proposal seeks to further understand the contribution of the PIK3CA mutations in colon cancer, by correlating the type of hotspot mutation with the development of metastases in stage II and stage Ill patients. In order to do this, DNA will be extracted from either frozen or paraffin embedded colon cancer tissues to sequence PIK3CA, KRAS and BRAF. Clinical outcome data will be gathered to include metastases and survival to correlate with PIK3CA, KRAS and BRAF mutational status. Patients with stage II and stage Ill colon cancers will be identified in the University of New Mexico Human Tissue Repository and the NIH PLCO prevention trial biorepository. Existing banked tissues of stage II and Ill colon cancers will be collected. There will be no direct contact with living individuals. Epidemiological factors such as age, race, gender and outcome data of metastases and survival will be collected.
Primary Outcome
Develop and standardize methods for high throughput DNA extraction and analysis from colon tumors of patients with stage II and stage Ill disease harboring PIK3CA exon 9 and exon 20 mutations. Currently, commercially available kits to assay for the Pl3K mutations rely on Sanger sequencing of DNA products extracted from formalin fixed paraffin embedded (FFPE) tissues. The presence of a pseudogene on chromosome 22 can interfere with the detection of helical domain mutations. A pyrosequencing tech
Interventions
- OTHER Non-interventional
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2012-05-22 |
| Est. Completion | 2019-10-21 |
What the finished NCT03951389 record still lists
NCT03951389 is an observational study that tracks outcomes without assigning an intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Non-interventional is the first listed.
NCT03951389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03951389 about?
NCT03951389 is a clinical study titled "INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer". This proposal seeks to further understand the contribution of the PIK3CA mutations in colon cancer, by correlating the type of hotspot mutation with the development of metastases in stage II and stage Ill patients. In order to do this, DNA will be extracted from either frozen or paraffin embedded c...
What is the current status of trial NCT03951389?
This trial is currently completed. The enrollment target is 750 participants. The study started on 2012-05-22. Estimated completion is 2019-10-21.
What interventions are being tested in trial NCT03951389?
The interventions under investigation include: Non-interventional (OTHER).
Who is sponsoring clinical trial NCT03951389?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
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