Liver CancerPREMED-CHCNCT06146127
Precision Medicine for Combined Hepatocellular-Cholangiocarcinoma
An observational study of Liver Cancer, run by Inserm U955 at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- phenotyping
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2001to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: adults
Who may be able to join
- histological diagnosis of combined tumor biological sample available
Who cannot join
- unequivocal histological features
Trial locations and contacts
1 site in 1 country.
Julien Calderaro contact
France1 site, 1 recruiting
- Recruiting
Julien Calderaro
Créteil, 94010
Julien Calderaro, julien.calderaro@aphp.fr
About this study
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.
Read the detailed 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.
- Conditions
- Liver Cancer
- Being tested
- phenotyping
- Keywords
- liver, cancer, precision medicine
- Medical subject headings
- Liver Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenotypingOther
Large scale molecular phenotyping
| Study group | Role | What they receive |
|---|---|---|
| Combined hepatocellular cholangiocarcinoma | Not described Receives: Other: phenotyping | |
| hepatocellular carcinoma | Not described Receives: Other: phenotyping | |
| cholangiocarcinoma | Not described Receives: Other: phenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosos
Tumor subgroups
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start15 Jan 2001
- Primary completion15 Jan 2023
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inserm U955
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Calderaro, Inserm U955
- Investigators
- Julien Calderaro, Principal investigator, Inserm/APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146127
- Sponsor's protocol ID
- PREMED-CHC
- Acronym
- PREMED-CHC
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine for Combined Hepatocellular-Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06146127
- Acronym / sponsor ID
- PREMED-CHC / PREMED-CHC
- Conditions
- Liver Cancer
- Keywords
- liver, cancer, precision medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Inserm U955University, hospital or other
- Study start
- 15 Jan 2001 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 24 Nov 2023 (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.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined hepatocellular cholangiocarcinoma | – | Other: phenotyping |
| hepatocellular carcinoma | – | Other: phenotyping |
| cholangiocarcinoma | – | Other: phenotyping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adults
Key inclusion criteria (1 listed)
- histological diagnosis of combined tumor biological sample available
Key exclusion criteria (1 listed)
- unequivocal histological features
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 |
|---|---|---|
| phenotypingLarge scale molecular phenotyping | Other | Combined hepatocellular cholangiocarcinoma, cholangiocarcinoma, hepatocellular carcinoma |
Primary outcome
Diagnosos
Time frame: 3 yrs
Tumor subgroups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Julien Calderaro contact
Julien Calderaro principal investigator
Inserm/APHP
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 Liver Cancer, run by Inserm U955 at 1 site in France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Calderaro (julien.calderaro@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosos (time frame: 3 yrs). 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 24 Nov 2023.