Clinical trial NCT06314958: Stage II/III Colorectal Cancer Recurrence
Official title: Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colorectal Adenocarcinoma
Colorectal Cancer Stage II
Colorectal Cancer Stage III
Colorectal Cancer Recurrent
Keywords: Recurrence-free Survival (RFS)
Overall Survival (OS)
Methylation
DNA methylation
carcinoembryonic antigen (CEA)
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two independent cohorts of colorectal cancer survivors (high-risk stage II and stage III), who received curative-intent surgery and adjuvant chemotherapy

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.

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

Eligibility 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

Primary outcomes:
measure: Recurrence-Free Survival
timeFrame: Up to 120 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 120 months
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: City of Hope Medical Center
state: California
city: Dalian
country: China
facility: Second Affiliated Hospital of Dalian Medical University
city: Barcelona
country: Spain
facility: Barcelona University
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: City of Hope Medical Center
name: Ajay Goel, PhD
role: PRINCIPAL_INVESTIGATOR
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