the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients

June 2, 2020 updated by: Anthony LOPEZ, Central Hospital, Nancy, France

Multicenter Retrospective Study Evaluating the Impact of Early Palliative Care on the Survival of Patients With Locally Advanced and / or Metastatic Cholangiocarcinoma (CCK)

The prognosis for cholangiocarcinoma is bad. Potentially, early management by a palliative care team could increase overall survival. We will also assess whether early management by a palliative care team could impact progression-free survival, the place of death and the date of the last chemotherapy, in particular to avoid unnecessary chemotherapy cures in an imminent end of life

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • Lopez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cholangiocarcinoma metastatic or locally advanced

Description

Inclusion Criteria:

  • Age> 18 years old
  • intra- or extra-hepatic CCK or histologically proven vesicular adenocarcinoma
  • Locally advanced and / or metastatic disease from the start or recurrent
  • Initial diagnosis or recurrence between 1/01/2013 and 31/12/2019

Exclusion Criteria:

  • <18 years old
  • death less than one week after the diagnostic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cholangiocarcinoma with early palliative care
Other: early palliative care
early palliative care
cholangiocarcinoma without early palliative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global survival
Time Frame: baseline
Global survival from the diagnosis (to the death or because of lost to follow up)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Anthony Lopez, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019PI274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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