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

Mayo Clinic

Status: Invitation-only

Conditions: Cholangiocarcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06474091

NCI-2024-04798 (Registry Identifier)

23-013283 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• * Patient has a 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

Trial design

500 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study