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NCT06314958 | RECRUITING | Colorectal Cancer

Stage II/III Colorectal Cancer Recurrence
Sponsor:

City of Hope Medical Center

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.

Condition or disease

Colorectal Cancer

Colorectal Adenocarcinoma

Colorectal Cancer Stage II

Colorectal Cancer Stage III

Colorectal Cancer Recurrent

Intervention/treatment

CENSURE

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

Study Type : OBSERVATIONAL
Estimated Enrollment : 400 participants
Official Title : Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment
Actual Study Start Date : 2023-03-15
Estimated Primary Completion Date : 2026-06-18
Estimated Study Completion Date : 2026-06-18

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Stage II/III Colorectal Cancer Recurrence

Location Details

NCT06314958

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope Medical Center

Monrovia, California, United States, 91016

RECRUITING

China,

Second Affiliated Hospital of Dalian Medical University

Dalian, China,

RECRUITING

Spain,

Barcelona University

Barcelona, Spain,

RECRUITING

Spain,

La Paz University Hospital

Madrid, Spain,