Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma

Hepatocellular Carcinoma Clinical Trial

— CHC/CC  

Official title:

Cohort Study of Patients With Primary Hepatocellular Carcinoma or Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340986
• Other study ID #: APHP190473
• Secondary ID: IDRCB 2019-A0167
• Status: Recruiting
• Start date: September 2, 2020
• Est. completion date: September 2030

Study information

• Verified date: June 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie LEQUOY, MD
• Phone: +330149283154
• Email: marie.lequoy[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: September 2030
• Est. primary completion date: September 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
France	Serviec hépatologie-Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Hepatocellular carcinoma and Cholangiocarcinoma : Overall survival is defined as the survival 5 years after the inclusion.	5 years
Secondary	Overall survival	Hepatocellular carcinoma :Overall survival is defined as the survival after 5 years of inclusion.	5 years
Secondary	Disease free survival	Cholangiocarcinoma : 2 and 5 years after surgical resection	2 and 5 years
Secondary	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%)	Time of progression under chemotherapy up to 5 years