Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma (CHC/CC)

April 7, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75012
        • Serviec hépatologie-Hôpital Saint Antoine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with hepatocellular carcinoma or cholangiocarcinoma treated in Saint-Antoine hospital

Description

Inclusion Criteria:

Inclusion Criteria :

  • 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

Exclusion Criteria:

- Lack of patient non-opposition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with Hepatocellular carcinoma
patients with Cholangiocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Hepatocellular carcinoma and Cholangiocarcinoma : Overall survival is defined as the survival 5 years after the inclusion.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Hepatocellular carcinoma :Overall survival is defined as the survival after 5 years of inclusion.
5 years
Disease free survival
Time Frame: 2 and 5 years
Cholangiocarcinoma : 2 and 5 years after surgical resection
2 and 5 years
Progression time under chemotherapy
Time Frame: Time of progression under chemotherapy up to 5 years
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%)
Time of progression under chemotherapy up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marie LEQUOY, MD, AssistancePublique-Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2030

Study Completion (ANTICIPATED)

April 1, 2030

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190473
  • IDRCB 2019-A01679-48 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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