Stage II/III Colorectal Cancer Recurrence

Part of paid clinical trials in Monrovia, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06314958
Status
Recruiting

Conditions

  • Colorectal Adenocarcinoma
  • Colorectal Cancer
  • Colorectal Cancer Recurrent
  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 15, 2023
Status verified
Jul 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterMonroviaCalifornia91016
Ajay Goel, PhD
626-218-3452
Caiming Xu, MD, PhD (PRINCIPAL_INVESTIGATOR)
Ajay Goel, PhD (PRINCIPAL_INVESTIGATOR)
Alessandro Mannucci, MD (SUB_INVESTIGATOR)

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