Institut Paoli Calmettes Hepatic Surgery Database | NCT03686137

Studies
Institut Paoli Calmettes Hepatic Surgery Database

NCT03686137

Sponsor

Institut Paoli-Calmettes

Status

Recruiting

Last Update Posted

Sep 26, 2018Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Liver Surgery

Interventions

Data collection

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2017Actual

Primary Completion Date

Nov 2030Estimated

Completion Date

Nov 2030Estimated

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 26, 2018Actual

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

Sep 25, 2018

Last Update Posted Date

Sep 26, 2018Actual

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

Database of patients who undergo hepatic surgery for: benign diseases, primary or secondary liver cancer at Institut Paoli-Calmettes

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

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Institut Paoli-Calmettes patients undergoing liver surgery			Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	Colelction of pre-operative, surgical and post-surgical data	Institut Paoli-Calmettes patients undergoing liver surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Epidemiological description	Epidemiological description of the patients who undergo hepatic surgery at Institut Paoli-Calmettes	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing liver surgery for benign liver tumor, primary or secondary liver cancer

Exclusion Criteria:

Patient refusal

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

Patient treated at Institut Paoli-Calmettes who undergo liver surgery for benign liver tumor, primary or secondary liver cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dominique Genre, MD	Contact	+33491223778		drci.up@ipc.unicancer.fr
Sandra Cournier	Contact	+33491223778		drci.up@ipc.unicancer.fr

Overall Officials

Name	Affiliation	Role
Ugo Marchese	Institut Paoli-Calmettes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Paoli Calmettes	Recruiting	Marseille	Bouches Du Rhone	13009	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided