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

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: NCT04415190
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Anthony LOPEZ, Central Hospital, Nancy, France

Brief Summary:
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

Condition or disease Intervention/treatment
Cholangiocarcinoma Other: early palliative care

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Retrospective Study Evaluating the Impact of Early Palliative Care on the Survival of Patients With Locally Advanced and / or Metastatic Cholangiocarcinoma (CCK)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Group/Cohort Intervention/treatment
cholangiocarcinoma with early palliative care Other: early palliative care
early palliative care

cholangiocarcinoma without early palliative care



Primary Outcome Measures :
  1. Global survival [ Time Frame: baseline ]
    Global survival from the diagnosis (to the death or because of lost to follow up)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cholangiocarcinoma metastatic or locally advanced
Criteria

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

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): NCT04415190


Contacts
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Contact: Anthony Lopez 0383858585 a.lopez@chru-nancy.fr

Locations
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France
Lopez
Vandœuvre-lès-Nancy, France, 54500
Contact: Anthony Lopez    0383858585    a.lopez@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Anthony Lopez CHRU Nancy
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Responsible Party: Anthony LOPEZ, Dr Lopez, MCU, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04415190    
Other Study ID Numbers: 2019PI274
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms