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NCT06146127 Clinical Trial

Precision Medicine for Combined Hepatocellular-Cholangiocarcinoma

Liver Cancer Clinical Trial

— PREMED-CHC  

Official title:
Precision Medicine for Combined Hepatocellular-Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06146127
Other study ID # PREMED-CHC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2001
Est. completion date January 30, 2025

Study information
Verified date November 2023
Source Inserm U955
Contact Julien Calderaro
Email julien.calderaro@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

- 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 30, 2025
Est. primary completion date January 15, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: histological diagnosis of combined tumor biological sample available Exclusion Criteria: unequivocal histological features

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• phenotyping
Large scale molecular phenotyping

Locations
Country Name City State
France Julien Calderaro Créteil

Sponsors (1)
Lead Sponsor Collaborator
Inserm U955

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnosos Tumor subgroups 3 yrs
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