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