Chronic Lymphocytic Leukemia Registry Study - Multicenter... | NCT03197259

Studies
Chronic Lymphocytic Leukemia Registry Study - Multicenter Prospective National Study

NCT03197259

Sponsor

Fatih Demirkan, MD

Status

Recruiting

Last Update Posted

Mar 9, 2021Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Chronic Lymphocytic Leukemia
Del(17P)

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Mar 2021

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 1, 2017Actual

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

May 18, 2017

First Submission Date that Met QC Criteria

Jun 21, 2017

First Posted Date

Jun 23, 2017Actual

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

Mar 8, 2021

Last Update Posted Date

Mar 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fatih Demirkan, MD, Board member, Izmir Hematologic Diseases and Cancer Research Help AssociationSponsor-Investigator

Lead Sponsor

Fatih Demirkan, MDOTHER

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

A prospective, multicenter national observational study for patients diagnosed as chronic lymphocytic leukemia across 25 centers in Turkey

Detailed Description

The purpose of this study is to explore the history and real world management of patients diagnosed with CLL, provide insight into the management of CLL, and evaluate the effectiveness of first, second and subsequent therapeutic strategies employed in both the community and academic settings.

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

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First line therapy therapy protocol distrubition	The primary objective is to describe percentage of first line therapy protocols in patients initiated on therapy for CLL in the community and academic setting	36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed as CLL
18 years or older
Able and willing to provide the written informed consent

Exclusion Criteria:

Younger than 18 years

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

All patients diagnosed as CLL

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatih Demirkan, Prof	Contact	+90 542 515 17 80		fatihdemirkan@yahoo.com

Overall Officials

Name	Affiliation	Role
Fatih Demirkan, Prof	Dokuz Eylum Medical Faculty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dokuz Eylum Medical Favulty	Recruiting	Izmir			Turkey (Türkiye)

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
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
C538045	Chromosome 17 deletion

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