Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342440
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-03-26
Brief Title:
Early Detection of Advanced Adenomas and Colorectal Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
AACRC
Brief Summary:
This study aims to develop a highly sensitive specific and cost-effective blood assay for early detection of colorectal adenomas and cancer using advanced machine learning and state-of-the-art biological analyses
Detailed Description:
Colorectal cancer CRC is a significant global health concern ranking third in diagnosis and second in mortality Despite being potentially preventable it remains a leading cause of cancer-related deaths Traditional screening methods like fecal immunochemical testing FIT have shown benefits in reducing late-stage diagnoses but have not effectively prevented CRC incidence This is because tests like FIT can effectively detect the cancers but not the precursor lesions called adenomas On the other hand endoscopy-first approaches offer higher sensitivity for such adenomas and therefore lower the risk of developing CRC but face challenges such as invasiveness cost and patient compliance
Non-invasive tests are more appealing to patients than invasive tests and can increase participation rates Biomarker studies have shown promise but existing tests lack sensitivity for early-stage CRC and advanced adenomas AAs This is likely because they assume the same analyte can detect both CRC and AAs which may not be accurate due to differences in analyte release and the biological changes that occur during the adenoma-carcinoma sequence
This study proposes developing an innovative liquid biopsy test tailored for AAs and CRC to address this An ideal screening test should be minimally invasive highly sensitive and cost-effective This test would optimize patient compliance and resource allocation by detecting both conditions from a single blood draw More specifically circulating microRNA miRNA analysis shows promise tests based on cell-free microRNA cf-miRNA have demonstrated high sensitivity while those based on exosome-derived microRNA exo-miRNA offer high specificity Therefore combining both analytes in a single test could maximize sensitivity and specificity
This study will develop a non-invasive blood test for AA and CRC in four phases
1 Genome-wide profiling of cf-miRNA and exo-miRNA and selecting the best candidates for biomarker panels
2 Utilizing machine learning to identify promising candidates and train algorithms for detecting AAs and CRC separately based on results from quantitative polymerase chain reaction qPCR analysis
3 Combining these algorithms to create detection signatures for both conditions
4 Independently validating these signatures using diverse cohorts to ensure broad applicability and compare the effectiveness of the blood assay to standard care through retrospective and prospective studies
This study aims to develop a highly sensitive specific and cost-effective liquid biopsy for early detection of AAs and CRC Success could transform clinical practice by preventing CRC through early detection of pre-malignant lesions Innovations include incorporating pre-malignant lesions into screening and combining cf-miRNA and exo-miRNA biomarkers for accuracy This approach could reduce CRC mortality and incidence and pave the way for new clinical trials
Non-invasive tests are more appealing to patients than invasive tests and can increase participation rates Biomarker studies have shown promise but existing tests lack sensitivity for early-stage CRC and advanced adenomas AAs This is likely because they assume the same analyte can detect both CRC and AAs which may not be accurate due to differences in analyte release and the biological changes that occur during the adenoma-carcinoma sequence
This study proposes developing an innovative liquid biopsy test tailored for AAs and CRC to address this An ideal screening test should be minimally invasive highly sensitive and cost-effective This test would optimize patient compliance and resource allocation by detecting both conditions from a single blood draw More specifically circulating microRNA miRNA analysis shows promise tests based on cell-free microRNA cf-miRNA have demonstrated high sensitivity while those based on exosome-derived microRNA exo-miRNA offer high specificity Therefore combining both analytes in a single test could maximize sensitivity and specificity
This study will develop a non-invasive blood test for AA and CRC in four phases
1 Genome-wide profiling of cf-miRNA and exo-miRNA and selecting the best candidates for biomarker panels
2 Utilizing machine learning to identify promising candidates and train algorithms for detecting AAs and CRC separately based on results from quantitative polymerase chain reaction qPCR analysis
3 Combining these algorithms to create detection signatures for both conditions
4 Independently validating these signatures using diverse cohorts to ensure broad applicability and compare the effectiveness of the blood assay to standard care through retrospective and prospective studies
This study aims to develop a highly sensitive specific and cost-effective liquid biopsy for early detection of AAs and CRC Success could transform clinical practice by preventing CRC through early detection of pre-malignant lesions Innovations include incorporating pre-malignant lesions into screening and combining cf-miRNA and exo-miRNA biomarkers for accuracy This approach could reduce CRC mortality and incidence and pave the way for new clinical trials
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