Clinical trial NCT06474091: Liquid Biopsy MonitORing Of CholangioCarcinOma for Treatment Response and Prognostic Outcomes (MOROCCO)
Official title: Liquid Biopsy MonitORing Of CholangioCarcinOma for Treatment Response and Prognostic Outcomes (MOROCCO)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cholangiocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical diagnosis of cholangiocarcinoma under evaluation for surgical intervention with intent to cure.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Associate of PUMA levels with short term progression
timeFrame: Up to 5 years
measure: Associate of PUMA levels with progression free survival
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Nguyen H. Tran, MD
role: PRINCIPAL_INVESTIGATOR
References: