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

First listed
Mar 18, 2024
Start date
Mar 15, 2023
Status verified
Jul 2026
Primary completion
Jun 18, 2028
Completion
Jun 18, 2028

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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