Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381648
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-19
Brief Title:
Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma LyMIC
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-05
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:
LyMIC
Brief Summary:
Lymph node metastasis LNM is a major prognostic factor in intrahepatic cholangiocarcinoma ICC and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy Despite this there are currently no reliable biomarkers established to detect LNM in ICC
This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients
This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients
Detailed Description:
Intrahepatic cholangiocarcinoma ICC is a malignant tumor of the liver arising from epithelial cells of the biliary tract accounting for 10-15 of primary liver cancers and the incidence of ICC has increased rapidly worldwide over the past decade The long-term prognosis is dismal with a 5-year overall survival OS as low as 25-30 Many studies have highlighted lymph node metastasis as a strong predictor of poor prognosis in ICC patients prompting efforts such as appropriate lymphadenectomy to accurately predict disease stage and reduce outcomes associated with LNM Adequate lymphadenectomy in patients with suspected LNM is essential for achieving R0 resection and is a necessary component of complete cure and long-term survival The routine use of highly invasive lymphadenectomy in all patients remains controversial and lymphadenectomy rates for ICC range from 269 to 100 depending on the literature and are not universally adopted currently
Currently LNM is detected preoperatively by imaging but imaging alone is not sufficient to diagnose LNM as negative findings by imaging findings may have low sensitivity and may not rule out LNM Other attempts have been made to develop predictive scoring systems based on Carbohydrate antigen 19-9 CA 19-9 levels location of the primary tumor lymph node patterns on CT and MRI and other clinical factors to predict LNM in ICC but all these predictive systems rely heavily on judgment regarding lymph node size and tumor growth patterns are largely left to diagnostic imaging
This study seeks to validate a panel of more accurate and non-invasive biomarkers exo-miRNAs in preoperative blood samples Accurate preoperative detection of the presence of LNM would help provide clear criteria for ICC treatment decisions such as the implementation of elective lymphadenectomy or the addition of chemotherapy
Currently LNM is detected preoperatively by imaging but imaging alone is not sufficient to diagnose LNM as negative findings by imaging findings may have low sensitivity and may not rule out LNM Other attempts have been made to develop predictive scoring systems based on Carbohydrate antigen 19-9 CA 19-9 levels location of the primary tumor lymph node patterns on CT and MRI and other clinical factors to predict LNM in ICC but all these predictive systems rely heavily on judgment regarding lymph node size and tumor growth patterns are largely left to diagnostic imaging
This study seeks to validate a panel of more accurate and non-invasive biomarkers exo-miRNAs in preoperative blood samples Accurate preoperative detection of the presence of LNM would help provide clear criteria for ICC treatment decisions such as the implementation of elective lymphadenectomy or the addition of chemotherapy
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