Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma

Recruiting

• Conditions: Cholangiocarcinoma; Hepatocellular Carcinoma

• Registration Number: NCT04340986
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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 Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-10
• Study Start: 2020-09-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Primary Completion: 2030-09
• Study Completion: 2030-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	Hepatocellular carcinoma and Cholangiocarcinoma : Overall survival is defined as the survival 5 years after the inclusion.

Secondary Outcome Measures

Name	Time	Method
Disease free survival	2 and 5 years	Cholangiocarcinoma : 2 and 5 years after surgical resection
Overall survival	5 years	Hepatocellular carcinoma :Overall survival is defined as the survival after 5 years of inclusion.
Progression time under chemotherapy	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%)

Trial Locations

Locations (1)

Serviec hépatologie-Hôpital Saint Antoine; 🇫🇷 Paris, France