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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04340986
Other study ID # APHP190473
Secondary ID IDRCB 2019-A0167
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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