Trials / Recruiting
RecruitingNCT06314958
Stage II/III Colorectal Cancer Recurrence
Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Conditions
- Colorectal Cancer
- Colorectal Adenocarcinoma
- Colorectal Cancer Stage II
- Colorectal Cancer Stage III
- Colorectal Cancer Recurrent
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-03-15
- Primary completion
- 2026-06-18
- Completion
- 2026-06-18
- First posted
- 2024-03-18
- Last updated
- 2025-07-04
Locations
4 sites across 3 countries: United States, China, Spain
Source: ClinicalTrials.gov record NCT06314958. Inclusion in this directory is not an endorsement.