Liquid Biopsy MonitORing Of CholangioCarcinOma for Treatment Response and Prognostic Outcomes (MOROCCO)

• Conditions: Cholangiocarcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06474091
• Lead Sponsor: Mayo Clinic

Brief Summary

This study explores the potential value of a new blood test approach to detect measurable residual disease or early recurrence/progression 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.

Study Timeline

• Study Start: 2024-05-08
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Study First Posted: 2024-06-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2029-05-08
• Study Completion: 2029-05-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patient has a suspected or clinical diagnosis cholangiocarcinoma and under evaluation for surgical intervention with intent to cure
• Age ≥ 18 years

Exclusion Criteria

• Patient has metastatic disease involving other organs (excluding lymph node)
• Patent has known primary cancer outside of the bile ducts within the last 3 years prior to blood collection (not including basal cell or squamous cell skin cancers, indolent cancer not requiring treatment within 3 years i.e. kidney, prostate or thyroid being observed)
• Patient has had surgery to remove current target pathology completely or partially
• Patient has undergone any prior radiation therapy to target lesion prior to blood collection
• Patient has received chemotherapy class drugs in the 3 years prior to blood collection
• Patient has had any transplants prior to blood collection
• Current target pathology is a recurrence

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional 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.

Primary Outcome Measures

Name	Time	Method
Associate of PUMA levels with short term progression	Up to 5 years	Proteins, mUtations, Methylated DNA, and Aneuploidy (PUMA) markers will be assessed pre- and post-treatment and will be associated with treatment response to therapy (short term progression; time to cholangiocarcinoma recurrence).
Associate of PUMA levels with progression free survival	Up to 5 years	Pre-surgical and post-surgical PUMA levels will be associated with progression free survival (time to death from cholangiocarcinoma).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States