MedDataX Logo

Precision Medicine for Combined Hepatocellular-Cholangiocarcinoma

NCT ID: NCT06146127

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-15

Study Completion Date

2025-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our project is a large-scale characterisation of cHCC-CCA will allow us to determine which subsets harbor actionable gene alterations. We will also aim to improve diagnosis of this tumor type by the use of immunohistochemical biomarkers and the development of deep-learning based models able to help cHCC-CCA diagnosis. This will represent an important step towards precision medicine for the patients with this highly aggressive malignancy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* Scientific background Combined hepatocellular-cholangiocarcinoma (cHCC-CCA) is a rare liver cancer characterized by a dual hepatocytic and biliary differentiation. It is resistant to conventional anti-cancer treatments and there is currently no effective systemic therapy available. Inter-observer agreement for diagnosis of cHCC-CCA is low, even among expert pathologists, and the development of clinical trials remain thus challenging. The molecular mechanisms that drive its progression also remain under-investigated.
* Project objectives and brief description of the methods which will be used to achieve them We aim to perform an integrative molecular, immune and phenotypical study of cHCC-CCA that will allow the distinction of different tumor subgroups linked to particular actionable genetic/immune alterations. The development of immunohistochemical markers and artificial intelligence-based approaches is also likely to improve the diagnosis of cHCC-CCA.

A overall multicentric series of 357 cHCC-CCA samples, already available in our biobanks, will be investigated by means of gene and RNA sequencing, digital pathology and immunohistochemistry in order to build a morphomolecular classification of this tumor. Spatial transcriptomics and in situ proteomics will be performed to decipher the intra-tumor heterogeneity and identify biomarkers of the different subclasses. Finally, deep-learning based models will be developed in order to 1) improve the diagnosis of cHCC-CCA and 2) identify the morphological features linked to prognosis.

• Expected results This large-scale characterisation of cHCC-CCA will allow us to determine which subsets harbor actionable gene alterations. We will also aim to improve diagnosis of this tumor type by the use of immunohistochemical biomarkers and the development of deep-learning based models able to help cHCC-CCA diagnosis. This will represent an important step towards precision medicine for the patients with this highly aggressive malignancy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Combined hepatocellular cholangiocarcinoma

phenotyping

Intervention Type OTHER

Large scale molecular phenotyping

hepatocellular carcinoma

phenotyping

Intervention Type OTHER

Large scale molecular phenotyping

cholangiocarcinoma

phenotyping

Intervention Type OTHER

Large scale molecular phenotyping

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

phenotyping

Large scale molecular phenotyping

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

histological diagnosis of combined tumor biological sample available

Exclusion Criteria

unequivocal histological features
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inserm U955

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julien Calderaro

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julien Calderaro

Role: PRINCIPAL_INVESTIGATOR

Inserm/APHP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Julien Calderaro

Créteil, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julien Calderaro

Role: CONTACT

[email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julien Calderaro

Role: primary

[email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PREMED-CHC

Identifier Type: -

Identifier Source: org_study_id