Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-28 @ 7:17 PM
Study NCT ID:
NCT06314958
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2024-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stage II/III Colorectal Cancer Recurrence
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CENSURE
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: