Menu
Enrolling by invitation NCT06474091

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

— Observational Cholangiocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Cholangiocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Non-Interventional Study
    Non-Interventional Study

Primary outcome measures

  • Associate of PUMA levels with short term progression [Time frame: Up to 5 years]
  • Associate of PUMA levels with progression free survival [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

  • Patient has a suspected or clinical diagnosis of 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06474091 · 23-013283 · NCI-2024-04798 · 23-013283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗