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
About this trial
This is an interventional basic science trial for Acute Myeloid Leukemia focused on measuring PTK7, Acute Myeloid Leukemia
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
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
NCT ID
NCT02860793
First Posted
August 2, 2016
Last Updated
August 9, 2016
Sponsor
Institut Paoli-Calmettes
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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