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Role of PTK-7 in Acute Myeloid Leukemias (LAM-PTK7)

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bone marrow aspiration
Blood sampling
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Myeloid Leukemia focused on measuring PTK7, Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Paoli Calmettes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AML patients at diagnosis

Arm Description

Outcomes

Primary Outcome Measures

Evaluation PTK7+ and PTK7- AML cells hematopoietic homing abilities in xenografted mice by in vivo bioluminescence imaging
Soluble PTK7 measurement in the serum

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
August 9, 2016
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT02860793
Brief Title
Role of PTK-7 in Acute Myeloid Leukemias
Acronym
LAM-PTK7
Official Title
Role of PTK-7 in Acute Myeloid Leukemias: Impact of PTK7 Serum Marker and ex Vivo Studies to Decipher the Role of PTK7
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
PTK7, Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AML patients at diagnosis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Bone marrow aspiration
Intervention Type
Other
Intervention Name(s)
Blood sampling
Primary Outcome Measure Information:
Title
Evaluation PTK7+ and PTK7- AML cells hematopoietic homing abilities in xenografted mice by in vivo bioluminescence imaging
Time Frame
1 day
Title
Soluble PTK7 measurement in the serum
Time Frame
12 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert VEY, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
State/Province
Bouches du Rhone
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Role of PTK-7 in Acute Myeloid Leukemias

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