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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340986
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Cholangiocarcinoma Hepatocellular Carcinoma

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.

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Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of Patients With Primary Hepatocellular Carcinoma or Cholangiocarcinoma
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2030
Estimated Study Completion Date : April 2030

Resource links provided by the National Library of Medicine


Group/Cohort
patients with Hepatocellular carcinoma
patients with Cholangiocarcinoma



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Hepatocellular carcinoma and Cholangiocarcinoma : Overall survival is defined as the survival 5 years after the inclusion.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Hepatocellular carcinoma :Overall survival is defined as the survival after 5 years of inclusion.

  2. Disease free survival [ Time Frame: 2 and 5 years ]
    Cholangiocarcinoma : 2 and 5 years after surgical resection

  3. 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%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patients with hepatocellular carcinoma or cholangiocarcinoma treated in Saint-Antoine hospital
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340986


Contacts
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Contact: Marie LEQUOY, MD +330149283154 marie.lequoy@aphp.fr

Locations
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France
Serviec hépatologie-Hôpital Saint Antoine
Paris, France, 75012
Contact: Marie LEQUOY, MD    +330149283154    marie.lequoy@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marie LEQUOY, MD AssistancePublique-Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04340986    
Other Study ID Numbers: APHP190473
IDRCB 2019-A01679-48 ( Other Identifier: ANSM )
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
hepatocellular carcinoma
cholangiocarcinoma
cohort
Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Liver Diseases