NCT04415190

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

Same day

First QC Date

May 29, 2020

Last Update Submit

June 2, 2020

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Global survival

    Global survival from the diagnosis (to the death or because of lost to follow up)

    baseline

Study Arms (2)

cholangiocarcinoma with early palliative care

Other: early palliative care

cholangiocarcinoma without early palliative care

Interventions

early palliative careOTHER

early palliative care

cholangiocarcinoma with early palliative care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cholangiocarcinoma metastatic or locally advanced

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lopez

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Anthony Lopez

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Lopez

CONTACT

0383858585a.lopez@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Lopez, MCU

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 4, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2020

Study Completion

December 31, 2020

Last Updated

June 4, 2020

Record last verified: 2020-05

Locations

FR(1)