Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271980
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-02-15
Brief Title:
Early-Onset Colorectal Cancer Recurrence
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Predicting Long-Term Recurrence-Free and Overall Survival in Early-Onset Colorectal Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2024-03
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:
ENCORE
Brief Summary:
Survivors of early-onset colorectal cancer diagnosed before age 50 may experience colorectal cancer recurrence several years after curative-intent treatments but clinical guidelines provide unclear guidance on endoscopic surveillance
This study aims to predict recurrence-free survival and overall survival in survivors of early-onset colorectal cancer using a tumor-based molecular assay based on microRNA ribonucleic acid
This study aims to predict recurrence-free survival and overall survival in survivors of early-onset colorectal cancer using a tumor-based molecular assay based on microRNA ribonucleic acid
Detailed Description:
Colorectal cancer CRC once predominantly affected older individuals but in recent years has witnessed a progressive increase in incidence among young adults Once rare early-onset colorectal cancer EOCRC that is a CRC diagnosed before the age of 50 now constitutes 10-15 of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men in the US and the second for young women In the wake of the increasing incidence the growing population of EOCRC survivors introduces distinctive clinical challenges
Patients with EOCRC are hypothesized to possess a more biologically active colorectum susceptible to malignant transformation both earlier in life and later after primary cancer Indeed EOCRC survivors encounter an elevated risk of disease recurrence a risk that may manifest years after primary treatment These considerations have prompted a trend toward offering more aggressive therapy or endoscopy surveillance a practice however not substantiated by evidence yet Scientific societies have also adopted a cautious stance recognizing the elevated risk while acknowledging the absence of evidence to substantiate an intensified surveillance protocol which might constitute overtreatment
In this research effort the investigators will leverage machine learning to predict recurrence-free survival RFS and overall survival OS in patients cured of EOCRC The research plan will employ three phases
1 After a systematic discovery phase based on small RNA sequencing the investigators will identify a panel of candidate biomarkers
2 The investigators will then develop an assay based on reverse transcription-quantitative polymerase chain reaction RT-qPCR and train a machine-learning model to predict recurrence-free and overall survival outcomes
3 The investigators will independently validate the assay
This assay is provisionally termed ENCORE Early oNset COlorectal cancer REcurrence and will be tested for recurrence-free and overall survival outcomes up to ten years after treatment
At the end of this study this assay will have been developed and validated to help clinical decision-making by predicting both recurrence-free and overall survival in EOCRC survivors
Patients with EOCRC are hypothesized to possess a more biologically active colorectum susceptible to malignant transformation both earlier in life and later after primary cancer Indeed EOCRC survivors encounter an elevated risk of disease recurrence a risk that may manifest years after primary treatment These considerations have prompted a trend toward offering more aggressive therapy or endoscopy surveillance a practice however not substantiated by evidence yet Scientific societies have also adopted a cautious stance recognizing the elevated risk while acknowledging the absence of evidence to substantiate an intensified surveillance protocol which might constitute overtreatment
In this research effort the investigators will leverage machine learning to predict recurrence-free survival RFS and overall survival OS in patients cured of EOCRC The research plan will employ three phases
1 After a systematic discovery phase based on small RNA sequencing the investigators will identify a panel of candidate biomarkers
2 The investigators will then develop an assay based on reverse transcription-quantitative polymerase chain reaction RT-qPCR and train a machine-learning model to predict recurrence-free and overall survival outcomes
3 The investigators will independently validate the assay
This assay is provisionally termed ENCORE Early oNset COlorectal cancer REcurrence and will be tested for recurrence-free and overall survival outcomes up to ten years after treatment
At the end of this study this assay will have been developed and validated to help clinical decision-making by predicting both recurrence-free and overall survival in EOCRC survivors
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?:
None