Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma

NCT04340986 | Recruiting

• 2 other identifiers: APHP190473IDRCB 2019-A01679-48
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma; Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; cholangiocarcinoma; cohort

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  5 years

Secondary Outcomes (3)

• Overall survival

  5 years

• Disease free survival

  2 and 5 years

• Progression time under chemotherapy

  Time of progression under chemotherapy up to 5 years

Study Arms (2)

patients with Hepatocellular carcinoma

patients with Cholangiocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- Lack of patient non-opposition

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Serviec hépatologie-Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Marie LEQUOY, MD

  AssistancePublique-Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie LEQUOY, MD

CONTACT

+330149283154; marie.lequoy@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: September 2, 2020
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)