Recruiting

Observational Study

Sponsor:

City of Hope Medical Center

Code:

NCT06314958

Conditions

Colorectal Cancer

Colorectal Adenocarcinoma

Colorectal Cancer Stage II

Colorectal Cancer Stage III

Colorectal Cancer Recurrent

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CENSURE

Study Details

Brief summary:

This study will develop an assay to predict disease recurrence in patients with stage II/III CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation.

Conditions

Colorectal Cancer

Colorectal Adenocarcinoma

Colorectal Cancer Stage II

Colorectal Cancer Stage III

Colorectal Cancer Recurrent

Study ID

NCT06314958

Start date

Mar 15, 2023

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Stage II (high-risk) or III colorectal cancer (TNM classification, 8th edition).
  • Received standard diagnostic, staging, and therapeutic procedures as per local guidelines
  • Received stage-specific curative-intent resection followed by adjuvant chemotherapy.
  • Confirmed cancer-free survivorship confirmed at the time of study inclusion.

Exclusion Criteria:

  • Lack of written informed consent.
  • Development of recurrence in the first 6 months following adjuvant chemotherapy completion.
  • Hereditary colorectal cancer syndromes (identified through genetic testing)
  • Inflammatory bowel diseases

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Stage II/III Colorectal Cancer, with Recurrence (Training)

Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.

Stage II/III Colorectal Cancer, without Recurrence (Training)

Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and did not experience recurrence within five years.

Stage II/III Colorectal Cancer, with Recurrence (Validation)

Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.

Stage II/III Colorectal Cancer, without Recurrence (Validation)

Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and did not experience recurrence within five years.

Interventions

CENSURE

A panel of CpG sites, whose methylation level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.

Primary outcome measure

  • Recurrence-Free Survival [ Time Frame: Up to 120 months ]

Central Contacts and Locations

Central contacts

Ajay Goel, PhD

6262183452AJGOEL@COH.ORG

Locations

City of Hope Medical Center

Recruiting

Monrovia, California, United States, 91016

Contacts

Ajay Goel, PhD

626-218-3452AJGOEL@COH.ORG

Principal Investigator:

Caiming Xu, MD, PhD

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Recurrence-free Survival (RFS)
  • Overall Survival (OS)
  • Methylation
  • DNA methylation
  • carcinoembryonic antigen (CEA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.