Role of PTK-7 in Acute Myeloid Leukemias | NCT02860793

Studies
Role of PTK-7 in Acute Myeloid Leukemias

NCT02860793

Sponsor

Institut Paoli-Calmettes

Status

Completed

Last Update Posted

Aug 10, 2016Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Acute Myeloid Leukemia

Interventions

Bone marrow aspiration
Blood sampling

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Not provided

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 8, 2016

First Posted Date

Aug 9, 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 9, 2016

Last Update Posted Date

Aug 10, 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

Description Module

Brief Summary

The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to convey promigratory and antiapoptotic signals into the cell and represents an independent prognosis factor of survival in patients treated with induction chemotherapy. This study aims at:

evaluating the impact of PTK7 expression on primary AML cells ex vivo
evaluating the diagnostic and prognostic value of a soluble form of PTK7

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AML patients at diagnosis	Experimental		Other: Bone marrow aspiration Other: Blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone marrow aspiration	Other		AML patients at diagnosis
Blood sampling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation PTK7+ and PTK7- AML cells hematopoietic homing abilities in xenografted mice by in vivo bioluminescence imaging		1 day
Soluble PTK7 measurement in the serum		12 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age> 18 years
AML at diagnosis, not previously treated
Treatment by induction chemotherapy
Signed informed consent
Affiliation to the French social security system

Exclusion Criteria:

pregnant woman(or of childbearing potential) or breastfeeding woman
emergency
patients deprived of liberty or placed under the authority of a tutor

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Norbert VEY, MD	Institut Paoli-Calmettes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Paoli Calmettes		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

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided