Ignite Creation Date:
2024-05-06 @ 1:10 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03951389
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2019-05-08
Brief Title:
INST 1204 PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
INST 1204 PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None