Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02877056

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopy

Study Details

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.

Conditions

Colorectal Cancer

Study ID

NCT02877056

Start date

Aug, 2005

Status verified date

May, 2019

Completion date

Aug, 2023

Anticipated

Primary completion date

Aug, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients with colorectal adenocarcinoma (diagnosis based on either MDACC or outside records)
2. Patients scheduled to undergo neoadjuvant therapy per MDACC care team.
3. Patients over 18 years of age.
4. Patients with distant organ findings deemed to be indeterminate or metastatic will be enrolled at the surgeon's discretion.
5. Patients who have been deemed medically safe to undergo endoscopic biopsy by the physician performing the procedure.
6. 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.

Exclusion Criteria:

N/A

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Colorectal Cancer

Participants undergo standard endoscopy before therapy. Tissue samples taken from the tumor and normal colorectal tissue.

Interventions

Endoscopy

Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy.

Primary outcome measure

  • Predictive Tumor Cell Biomarkers After Chemoradiation Treatment for Colorectal Cancer [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 29, 2019

Last verified

May, 2019

Keywords

  • Colorectal adenocarcinoma
  • Neoadjuvant therapy
  • Endoscopy
  • Endoscopic biopsy
  • Biomarkers
  • Genes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2019-05-29.