the Impact of Early Palliative Care on the Survival of Lo... | NCT04415190

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

NCT04415190

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jun 4, 2020Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Cholangiocarcinoma

Interventions

early palliative care

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Estimated

Primary Completion Date

Jun 1, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

May 29, 2020

First Submission Date that Met QC Criteria

Jun 2, 2020

First Posted Date

Jun 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2020

Last Update Posted Date

Jun 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anthony LOPEZ, Dr Lopez, MCU, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cholangiocarcinoma with early palliative care			Other: early palliative care
cholangiocarcinoma without early palliative care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
early palliative care	Other	early palliative care	cholangiocarcinoma with early palliative care

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cholangiocarcinoma metastatic or locally advanced

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anthony Lopez	Contact	0383858585		a.lopez@chru-nancy.fr

Overall Officials

Name	Affiliation	Role
Anthony Lopez	CHRU Nancy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lopez		Vandœuvre-lès-Nancy		54500	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided