Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314971
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
Predicting Local and Distant Recurrence in T1 Colorectal Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Predicting Recurrence After Curative-Intent Resection of T1 Colorectal Cancer With Transcriptomics
Status:
RECRUITING
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:
T1CR
Brief Summary:
Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers T1 CRC Despite this there are currently no reliable biomarkers established to predict recurrence in T1 CRC
This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC
This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC
Detailed Description:
The incidence of invasive submucosal colorectal cancer T1 CRC is increasing likely as a reflection of improved screening and endoscopy use Current treatment options for T1 CRC focus on less invasive methods ie endoscopic submucosal dissection and treatment decisions are based on the risk of lymph node metastasis LNM Up to 70-80 of T1 CRC patients may undergo surgery with adjuvant chemotherapy recommended only for those with LNM
However current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone This results in the overtreatment of many patients especially those that are currently defined as high-risk T1 CRC Existing surveillance methods may not adequately predict the prognosis of T1 CRC lacking established biomarkers for assessing disease-free survival
This study seeks to validate tissue-based biomarkers micro-RNA and messenger RNA that are associated with tumor recurrence after curative resection The identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy Previous research by this group has identified miRNA signatures for detecting postoperative tumor recurrence and metastasis in CRC highlighting their potential as biomarkers for disease progression
However current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone This results in the overtreatment of many patients especially those that are currently defined as high-risk T1 CRC Existing surveillance methods may not adequately predict the prognosis of T1 CRC lacking established biomarkers for assessing disease-free survival
This study seeks to validate tissue-based biomarkers micro-RNA and messenger RNA that are associated with tumor recurrence after curative resection The identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy Previous research by this group has identified miRNA signatures for detecting postoperative tumor recurrence and metastasis in CRC highlighting their potential as biomarkers for disease progression
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