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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-08

Study Completion Date

2029-05-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cholangiocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Patients undergo collection of blood samples and have their medical records reviewed on study. Patients also undergo collection of archived tissue samples on study.

Non-Interventional Study

Intervention Type OTHER

Non-Interventional Study

Interventions

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Non-Interventional Study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No