Stage II/III Colorectal Cancer Recurrence

NCT06314958 | Recruiting

• 1 other identifier: 23228/CENSURE
• Study Type: observational
• Target: 400
• Locations: 3 countries
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival

  Time from treatment completion to development of recurrence (or death)

  Up to 120 months

Secondary Outcomes (1)

• Overall Survival

  Up to 120 months

Study Arms (4)

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.

Other: CENSURE

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.

Other: CENSURE

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.

Other: CENSURE

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.

Other: CENSURE

Interventions

CENSURE OTHER

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.

Also known as: CENSURE (CpG mEthylation-based epigeNetic SignatURE)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two independent cohorts of colorectal cancer survivors (high-risk stage II and stage III), who received curative-intent surgery and adjuvant chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (4)

City of Hope Medical Center

Monrovia, California, 91016, United States

RECRUITING

Second Affiliated Hospital of Dalian Medical University

Dalian, China

RECRUITING

Barcelona University

Barcelona, Spain

RECRUITING

La Paz University Hospital

Madrid, Spain

RECRUITING

Related Publications (19)

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Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed and paraffin-embedded samples derived from the primary tumor.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Goel, PhD

CONTACT

6262183452; AJGOEL@COH.ORG

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: March 15, 2023
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1); ES (2); CN (1)