INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer
NCT ID: NCT03951389
Last Updated: 2021-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
750 participants
OBSERVATIONAL
2012-05-22
2019-10-21
Brief Summary
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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.
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Detailed Description
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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.
Specific Aims:
1. To develop and standardize methods for high throughput DNA extraction and analysis from colon tumors of patients with stage II and stage III disease harboring PIK3CA exon 9 and exon 20 mutations.
2. To determine the correlation between wild type and PIK3CA, PIK3CA exon 9 and PIK3CA exon 20 mutations and development of metastatic disease and overall survival in stage II and stage III patients with colorectal cancer.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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Non-interventional
Non-interventional
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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New Mexico Cancer Research Alliance
OTHER
Responsible Party
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Principal Investigators
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Ashwani Rajput, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico Cancer Center
Locations
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University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Countries
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Other Identifiers
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INST 1204
Identifier Type: -
Identifier Source: org_study_id
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