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INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer

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ClinicalTrials.gov Identifier: NCT03951389
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Colon Cancer Other: Non-interventional

Detailed Description:

This proposal aims to identify PIK3CA mutations as a biomarker for metastasis.

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer
Actual Study Start Date : May 22, 2012
Estimated Primary Completion Date : December 31, 2031
Estimated Study Completion Date : December 31, 2032
Groups and Cohorts
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Intervention Details:
  • Other: Non-interventional
    Non-interventional

Outcome Measures
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Primary Outcome Measures :
  1. The best standardized method for high throughput DNA extraction and analysis from colon tumors of patients [ Time Frame: Through study completion, up to 20 years ]

    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 technique which allows one to "sequence by synthesis" has been developed to allow the detection of the hotspot PIK3CA mutations without interference from this pseudogene. The investigators propose to modify and expand this pyrosequencing technique to include the additional mutations identified in exons 9 and 20, allowing identifications of nearly 85% of all PIK3CA mutations. Prior to sequencing the investigators will op


  2. The correlation between wild type PIK3CA, PIK3CA exon 9 and PIK3CA exon 20 mutations and developing of metastatic disease and overall colorectal patient survival [ Time Frame: Through study completion, up to 20 years ]
    Tissues from stage II and stage Ill colorectal cancer patients have been identified in the University of New Mexico (UNM) Human Tissue Repository (HTR) and will be available for analysis. Clinical follow up data including the development of metastases, site(s) of metastases and overall survival will be collected from a combination of the tumor registry and the medical records. Additional formalin fixed paraffin embedded tissues from patients with stage II and Ill colorectal cancer will be available from the NCI Prostate, Lung, Colon, Ovary Prevention Trial. Extensive clinical follow-up and survival data are already annotated for patients in this trial and will be available for analysis. Correlation between wild type PIK3CA, exon 9 and exon 20 PIK3CA mutants, KRAS and BRAF mutational status and the occurrence of metastases will be determined. Survival curves will also be generated based on mutational status of the genes listed above.


Biospecimen Retention:   Samples With DNA
Either frozen or paraffin embedded colon cancer tissues

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Specimen from patients with stage II and stage III colon cancer.
Criteria

Inclusion Criteria:

  • Specimen from patients with stage II and stage III colon cancer.

Exclusion Criteria:

  • Any other stage or type of disease outside of stage II and stage III colon cancer.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951389


Contacts
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Contact: Amy Overby 505-272-5557 Aoverby1@salud.unm.edu
Contact: Karen Gaines, BS 505-925-0353 kgaines@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Comprehensive Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Ashwani Rajput, MD    505-925-4782    arajput@salud.unm.edu   
Principal Investigator: Ashwani Rajput, MD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
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Principal Investigator: Ashwani Rajput, MD University of New Mexico Cancer Center
More Information
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Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT03951389    
Other Study ID Numbers: INST 1204
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases