Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04739072

Conditions

Colorectal Adenocarcinoma

Stage I Colorectal Cancer AJCC v8

Stage II Colorectal Cancer AJCC v8

Stage IIA Colorectal Cancer AJCC v8

Stage IIB Colorectal Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Study Details

Brief summary:

This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules/chemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread.

Conditions

Colorectal Adenocarcinoma

Stage I Colorectal Cancer AJCC v8

Stage II Colorectal Cancer AJCC v8

Stage IIA Colorectal Cancer AJCC v8

Stage IIB Colorectal Cancer AJCC v8

Study ID

NCT04739072

Start date

Nov 22, 2019

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years.
2. Histological/cytological confirmation of colorectal adenocarcinoma.
3. Patients with any stage colorectal adenocarcinoma deemed potentially eligible for curative intent treatment. Patients with stages II-IV colorectal cancer post-R0 resection may also be enrolled onto the protocol any time before or up to 3 months post-surgery and prior to initiating adjuvant therapy.
4. Ability to understand and the willingness to sign a written informed consent document.
5. Willing to pursue standard of care surveillance post completion of curative therapies.
6. Willing to provide blood samples for correlative research.

Exclusion Criteria:

1. Known active malignancies other than colorectal adenocarcinoma that may interfere with detection and / or interpretation of circulating plasma markers. Patients with known clonal hematopoiesis of indeterminate potential are eligible.
2. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-correlative (biospecimen collection)

Patients undergo collection of blood samples at baseline, during each neoadjuvant therapy treatment, prior to surgical resection, and up to 4 times per year for up to 5 years. Patients also undergo collection of tissue sample at time of surgical resection. Patients medical records may also be reviewed.

Interventions

Biospecimen Collection

Undergo collection of blood and tissue samples

Electronic Health Record Review

Review of medical records

Primary outcome measure

  • Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma [ Time Frame: Up to 5 years ]
  • Detection of recurrences post completion of curative therapies [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Arvind Dasari

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 29, 2026

Last verified

May, 2026

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 2026-05-29.