CholangiocarcinomaNCT06474091
Liquid Biopsy MonitORing Of CholangioCarcinOma for Treatment Response and Prognostic Outcomes (MOROCCO)
An observational study of Cholangiocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to 8 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a clinical diagnosis of cholangiocarcinoma under evaluation for surgical intervention with intent to cure.
Who may be able to join
- Patient has a suspected or clinical diagnosis of cholangiocarcinoma and under evaluation for surgical intervention with intent to cure
- Age ≥ 18 years
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Cholangiocarcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start8 May 2024
- Primary completion8 May 2029 (estimated)
- Study completion8 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nguyen H. Tran, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474091
- Sponsor's protocol ID
- 23-013283
- Other IDs
- NCI-2024-04798, 23-013283
- Status last verified
- Mar 2026
- First submitted
- 19 Jun 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy MonitORing Of CholangioCarcinOma for Treatment Response and Prognostic Outcomes (MOROCCO)
- ClinicalTrials.gov ID
- NCT06474091
- Acronym / sponsor ID
- 23-013283
- Conditions
- Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 8 May 2029 (estimated)
- Study completion
- 8 May 2029 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo collection of blood samples and have their medical records reviewed on study. Patients also undergo collection of archived tissue samples on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical diagnosis of cholangiocarcinoma under evaluation for surgical intervention with intent to cure.
Key inclusion criteria (2 listed)
- Patient has a suspected or clinical diagnosis of cholangiocarcinoma and under evaluation for surgical intervention with intent to cure
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Observational |
Primary outcome
Associate of PUMA levels with short term progression
Time frame: Up to 5 years
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).
Associate of PUMA levels with progression free survival
Time frame: Up to 5 years
Pre-surgical and post-surgical PUMA levels will be associated with progression free survival (time to death from cholangiocarcinoma).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nguyen H. Tran, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associate of PUMA levels with short term progression (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.