Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342401
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
Early Onset Colorectal Cancer Detection
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ENCODE
Brief Summary:
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 and the second for young women
This study aims to detect EOCRC with a non-invasive test using a blood-based molecular assay based on microRNA ribonucleic acid
This study aims to detect EOCRC with a non-invasive test using a blood-based molecular assay based on microRNA ribonucleic acid
Detailed Description:
The rising incidence of early-onset colorectal cancer EOCRC is a pressing clinical issue unique to our times and it is expected to grow with an anticipated further 90 increase in incidence by the decades end Challenges persist even after reducing the CRC screening age to 45 under-45s lack routine screening and compliance in the 45-50 age group remains low partly due to invasiveness and discomfort of standard screening methods Urgent action is warranted to develop affordable sensitive and feasible screening for timely detection and improved participation A non-invasive patient-friendly screening test like a blood-based assay could address these epidemiological concerns and also attract underserved populations
This study involves the development and validation of a liquid biopsy assessing circulating cell-free and exosomal microRNAs cf-miRNA and exo-miRNA respectively for indirect sampling of tumor tissue in the bloodstream The researchers intend to harness machine learning and bioinformatics to create an integrated panel with both cf-miRNAs and exo-miRNAs to enhance the inherently high sensitivity of cf-miRNAs with the distinctive specificity of exo-miRNAs This combined approach will not only improve the performance of a diagnostic model but will also tap into the diverse tumor biology aspects of EOCRC
The studys core goal is to develop cost-efficient non-invasive clinic-friendly biomarkers with high sensitivity and specificity aiding EOCRC detection
The researchers intend to do so in three phases
1 To perform comprehensive small RNA-Seq from matched cf-miRNA exo-miRNA cancer-derived miRNA and mucosa-derived miRNA
2 To develop and train two miRNA detection panels cf-miRNA and exo-miRNA respectively based on advanced machine-learning models and then combine these two using several machine-learning models to obtain a final detection biomarker
3 To validate the findings in an independent cohort of EOCRC and controls
In summary this proposal promises to improve patient care and compliance and ultimately reduce mortality from EOCRC
This study involves the development and validation of a liquid biopsy assessing circulating cell-free and exosomal microRNAs cf-miRNA and exo-miRNA respectively for indirect sampling of tumor tissue in the bloodstream The researchers intend to harness machine learning and bioinformatics to create an integrated panel with both cf-miRNAs and exo-miRNAs to enhance the inherently high sensitivity of cf-miRNAs with the distinctive specificity of exo-miRNAs This combined approach will not only improve the performance of a diagnostic model but will also tap into the diverse tumor biology aspects of EOCRC
The studys core goal is to develop cost-efficient non-invasive clinic-friendly biomarkers with high sensitivity and specificity aiding EOCRC detection
The researchers intend to do so in three phases
1 To perform comprehensive small RNA-Seq from matched cf-miRNA exo-miRNA cancer-derived miRNA and mucosa-derived miRNA
2 To develop and train two miRNA detection panels cf-miRNA and exo-miRNA respectively based on advanced machine-learning models and then combine these two using several machine-learning models to obtain a final detection biomarker
3 To validate the findings in an independent cohort of EOCRC and controls
In summary this proposal promises to improve patient care and compliance and ultimately reduce mortality from EOCRC
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