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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

Tracking Information
First Submitted Date May 8, 2019
First Posted Date May 15, 2019
Last Update Posted Date May 15, 2019
Actual Study Start Date May 22, 2012
Estimated Primary Completion Date December 31, 2031   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2019)
  • 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
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer
Official Title INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer
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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Either frozen or paraffin embedded colon cancer tissues
Sampling Method Non-Probability Sample
Study Population Specimen from patients with stage II and stage III colon cancer.
Condition Colon Cancer
Intervention Other: Non-interventional
Non-interventional
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 13, 2019)
750
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2032
Estimated Primary Completion Date December 31, 2031   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Amy Overby 505-272-5557 Aoverby1@salud.unm.edu
Contact: Karen Gaines, BS 505-925-0353 kgaines@salud.unm.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03951389
Other Study ID Numbers INST 1204
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party New Mexico Cancer Care Alliance
Study Sponsor New Mexico Cancer Care Alliance
Collaborators Not Provided
Investigators
Principal Investigator: Ashwani Rajput, MD University of New Mexico Cancer Center
PRS Account New Mexico Cancer Care Alliance
Verification Date May 2019