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

NCT06474091 | Enrolling By Invitation

• 2 other identifiers: 23-013283NCI-2024-04798
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (2)

• Associate of PUMA levels with short term progression

  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).

  Up to 5 years

• Associate of PUMA levels with progression free survival

  Pre-surgical and post-surgical PUMA levels will be associated with progression free survival (time to death from cholangiocarcinoma).

  Up to 5 years

Study Arms (1)

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinical diagnosis of cholangiocarcinoma under evaluation for surgical intervention with intent to cure.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Samples retained with permission of participant

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Nguyen H. Tran, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): May 8, 2029
• Study Completion (Estimated): May 8, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)