CholangiocarcinomaCHC/CCNCT04340986
Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma
An observational study of Cholangiocarcinoma and Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to describe the evolution of patients treated for a primary malignant hepatobiliary tumor (hepatocellular carcinoma or cholangiocarcinoma) over the long course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Hepatocellular Carcinoma
- How many people
- 1,250 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2020to Sep 2030
- 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
- Adult, Older adult
Study population: All patients with hepatocellular carcinoma or cholangiocarcinoma treated in Saint-Antoine hospital
Who may be able to join
- Age ≥ 18 years olds
- Medical care in Nephrology department since 2015
- Cholangiocarcinoma:
- Histologically and cytologically documented cholangiocarcinoma, regardless of the stage of the disease
- Hepatocellular carcinoma:
- Hepatocellular carcinoma at any stage of the disease, presenting the diagnostic criteria according to the diagnostic criteria of Barcelona : Tumor of more than 1 cm, developed on cirrhosis liver with arterial phase hyperenhancement and washout in the portal venous or delayed phases on CT and MRI
- Hepatocellular histologically documented
Who cannot join
- Lack of patient non-opposition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Serviec hépatologie-Hôpital Saint Antoine
Paris, 75012
Marie LEQUOY, MD, +330149283154, marie.lequoy@aphp.fr
About this study
Official title: Cohort Study of Patients With Primary Hepatocellular Carcinoma or Cholangiocarcinoma
The main objective is to describe the evolution of patients treated for a primary malignant hepatobiliary tumor (hepatocellular carcinoma or cholangiocarcinoma) over the long course.
Read the detailed description
The collection of data from patients with CHC and cholangiocarcinomas who are cancers with poor prognosis is a major challenge to improve patients'care (diagnosis, prognosis); facilitate the search for new therapeutic targets and the follow-up of clinical studies; and develop personalized treatments.
- Conditions
- Cholangiocarcinoma, Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, cholangiocarcinoma, cohort
- Medical subject headings
- Cholangiocarcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with Hepatocellular carcinoma | Not described | |
| patients with Cholangiocarcinoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Hepatocellular carcinoma and Cholangiocarcinoma : Overall survival is defined as the survival 5 years after the inclusion.
Measured: 5 years
Secondary outcomes (3)
Overall survival
Hepatocellular carcinoma :Overall survival is defined as the survival after 5 years of inclusion.
Measured: 5 years
Disease free survival
Cholangiocarcinoma : 2 and 5 years after surgical resection
Measured: 2 and 5 years
Progression time under chemotherapy
Cholangiocarcinoma : Time of progression under chemotherapy is defined by the delay between the start of chemotherapy and tumor progression (appearance of a new lesion or increase in size of more than 30%)
Measured: Time of progression under chemotherapy 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 posted10 Apr 2020
- Study start2 Sep 2020
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (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 Assistance Publique - Hôpitaux de ParisThe 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
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie LEQUOY, MD, Principal investigator, AssistancePublique-Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340986
- Sponsor's protocol ID
- APHP190473
- Other IDs
- IDRCB 2019-A01679-48
- Acronym
- CHC/CC
- Status last verified
- Jun 2024
- First submitted
- 7 Apr 2020
- Last updated
- 20 Jun 2024
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Patients With Primary Hepatocellular Carcinoma or Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT04340986
- Acronym / sponsor ID
- CHC/CC / APHP190473
- Conditions
- Cholangiocarcinoma, Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, cholangiocarcinoma, cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 10 Apr 2020 (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.
The main objective is to describe the evolution of patients treated for a primary malignant hepatobiliary tumor (hepatocellular carcinoma or cholangiocarcinoma) over the long course.
Detailed description
The collection of data from patients with CHC and cholangiocarcinomas who are cancers with poor prognosis is a major challenge to improve patients'care (diagnosis, prognosis); facilitate the search for new therapeutic targets and the follow-up of clinical studies; and develop personalized treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with Hepatocellular carcinoma | – | – |
| patients with Cholangiocarcinoma | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with hepatocellular carcinoma or cholangiocarcinoma treated in Saint-Antoine hospital
Key inclusion criteria (7 listed)
- Age ≥ 18 years olds
- Medical care in Nephrology department since 2015
- Histologically and cytologically documented cholangiocarcinoma, regardless of the stage of the disease
- Hepatocellular carcinoma at any stage of the disease, presenting the diagnostic criteria according to the diagnostic criteria of Barcelona : Tumor of more than 1 cm, developed on cirrhosis liver with arterial phase hyperenhancement and washout in the portal venous or delayed phases on CT and MRI
- Hepatocellular histologically documented
Key exclusion criteria (1 listed)
- Lack of patient non-opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5 years
Hepatocellular carcinoma and Cholangiocarcinoma : Overall survival is defined as the survival 5 years after the inclusion.
3 secondary outcomes
Overall survival
Time frame: 5 years
Disease free survival
Time frame: 2 and 5 years
Progression time under chemotherapy
Time frame: Time of progression under chemotherapy up to 5 years
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 20 Jun 2024.
- 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.
Marie LEQUOY, MD principal investigator
AssistancePublique-Hôpitaux de Paris
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 and Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris 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 7 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: looking for participants now, as of the sponsor's last update on 20 Jun 2024. 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?
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?
Contact Marie LEQUOY, MD (+330149283154, marie.lequoy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). 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 20 Jun 2024.