Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474091
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Liquid Biopsy MonitORing of CholangioCarcinOma for Treatment Response and Prognostic Outcomes MOROCCO
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Liquid Biopsy MonitORing of CholangioCarcinOma for Treatment Response and Prognostic Outcomes MOROCCO
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
None
Brief Summary:
This study explores the potential value of a new blood test approach to detect measurable residual disease or early recurrenceprogression in patients with cholangiocarcinoma
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the association of PUMA levels from peripheral blood with disease progression radiographically or clinically in patients that are candidates for curative surgical intervention of cholangiocarcinoma
Ia Pre- and post-neoadjuvant-treatment PUMA levels will be associated with treatment response to neoadjuvant therapy short term progression
Ib Pre-surgical and post-surgical PUMA levels will be associated with progression free survival
II To estimate the association of PUMA levels from peripheral blood with postoperative survival in patients treated for cholangiocarcinoma
OUTLINE This is an observational study
Patients undergo collection of blood samples and have their medical records reviewed on study Patients also undergo collection of archived tissue samples on study
I To estimate the association of PUMA levels from peripheral blood with disease progression radiographically or clinically in patients that are candidates for curative surgical intervention of cholangiocarcinoma
Ia Pre- and post-neoadjuvant-treatment PUMA levels will be associated with treatment response to neoadjuvant therapy short term progression
Ib Pre-surgical and post-surgical PUMA levels will be associated with progression free survival
II To estimate the association of PUMA levels from peripheral blood with postoperative survival in patients treated for cholangiocarcinoma
OUTLINE This is an observational study
Patients undergo collection of blood samples and have their medical records reviewed on study Patients also undergo collection of archived tissue samples on study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04798 | REGISTRY | None | None |
| 23-013283 | OTHER | None | None |