Print

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
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
    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.
    Other names:
    • CENSURE (CpG mEthylation-based epigeNetic SignatURE)
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
    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.
    Other names:
    • CENSURE (CpG mEthylation-based epigeNetic SignatURE)
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
    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.
    Other names:
    • CENSURE (CpG mEthylation-based epigeNetic SignatURE)
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
    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.
    Other names:
    • CENSURE (CpG mEthylation-based epigeNetic SignatURE)

Recruiting Locations

City of Hope Medical Center
Monrovia, California 91016
Contact:
Ajay Goel, PhD
626-218-3452
AJGOEL@COH.ORG

More Details

Status
Recruiting
Sponsor
City of Hope Medical Center

Study Contact

Ajay Goel, PhD
6262183452
AJGOEL@COH.ORG

Detailed Description

Adjuvant chemotherapy (ACT) is the standard clinical care for patients with stage III or high-risk stage II colorectal cancer (CRC) after curative-intent resection. Nonetheless, more than 30% of patients experience CRC recurrence. Accurate prediction of recurrence risk in stage II/III CRC patients who undergo ACT is crucial for determining the necessity and duration of ACT, as well as for tailoring novel treatment strategies for these patients. This study will comprise three phases 1. A systematic and comprehensive CpG methylation-based epigenetic biomarker discovery phase to identify the differentially methylated CpG sites associated with recurrence-free survival (RFS) < 5 years and > 5 years. In this phase, LASSO-based machine learning algorithms will be used to optimize the biomarker candidates. 2. A tissue-based clinical assay development phase by quantitative pyrosequencing 3. An independent validation phase. At completion, this study will validate a tissue-based assay to predict the development of recurrence after the completion of chemotherapy in patients with stage III and II CRC

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.