Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer
2 other identifiers
observational
250
1 country
1
Brief Summary
The goal of this laboratory research is to look for genes that can predict which patients will achieve a complete disappearance of their colorectal cancer after treatment like chemotherapy, radiation, or other therapy. This is an investigational study. Up to 350 patients will take part in this study. All will be enrolled at MD Anderson.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 17, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedMay 29, 2019
May 1, 2019
17 years
August 17, 2016
May 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Predictive Tumor Cell Biomarkers After Chemoradiation Treatment for Colorectal Cancer
Tissue taken at endoscopy undergoes testing for tumor cell biomarkers to identify patients who achieve complete response (CR).
1 day
Study Arms (1)
Colorectal Cancer
Participants undergo standard endoscopy before therapy. Tissue samples taken from the tumor and normal colorectal tissue.
Interventions
Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy.
Eligibility Criteria
Participants with Colorectal Cancer in the Gastrointestinal (GI) department at University of Texas MD Anderson Cancer Center.
You may qualify if:
- Patients with colorectal adenocarcinoma (diagnosis based on either MDACC or outside records)
- Patients scheduled to undergo neoadjuvant therapy per MDACC care team.
- Patients over 18 years of age.
- Patients with distant organ findings deemed to be indeterminate or metastatic will be enrolled at the surgeon's discretion.
- Patients who have been deemed medically safe to undergo endoscopic biopsy by the physician performing the procedure.
- Patients who would have typically undergone preoperative therapy followed by surgery but for specific reasons at the discretion of the treating physician underwent surgery without preoperative therapy may be enrolled at the surgeons' discretion.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy. Up to eight biopsy samples of the tumor as well as up to six biopsies of the grossly normal colorectum obtained.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Qian N. You, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2016
First Posted
August 24, 2016
Study Start
August 1, 2005
Primary Completion
August 1, 2022
Study Completion
August 1, 2023
Last Updated
May 29, 2019
Record last verified: 2019-05