Institut Paoli Calmettes Chronic Lymphatic Leukemia Database | NCT02869529

Studies
Institut Paoli Calmettes Chronic Lymphatic Leukemia Database

NCT02869529

Sponsor

Institut Paoli-Calmettes

Status

Recruiting

Last Update Posted

Aug 17, 2016Estimated

Enrollment

4,200Estimated

Phase

Not provided

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

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

Aug 2016

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

Jan 2006

Primary Completion Date

Jan 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Aug 11, 2016

First Submission Date that Met QC Criteria

Aug 16, 2016

First Posted Date

Aug 17, 2016Estimated

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

Aug 16, 2016

Last Update Posted Date

Aug 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,200Estimated

Label	Type	Description	Intervention Names
Chronic lymphatic leukemia diagnosis			Other: Data collection

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other		Chronic lymphatic leukemia diagnosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival of patients	Overall survival of all patients who come in the center	10 years

Secondary Outcomes

Measure	Description	Time Frame
Collection of patients characteristics	Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of chronic lymphatic leukemia

Exclusion Criteria:

Score of Matutes <4

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic lymphatic leukemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dominique Genre, MD	Contact	0033491223778		drci.up@ipc.unicancer.fr
Lilian Laborde	Contact	0033491223778		labordel@ipc.unicancer.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Paoli-Calmettes	Recruiting	Marseille	Bouches-du Rhône	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

Condition Browse Module

MeSH Terms

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

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