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

August 9, 2016 updated by: Institut Paoli-Calmettes

Role of PTK-7 in Acute Myeloid Leukemias: Impact of PTK7 Serum Marker and ex Vivo Studies to Decipher the Role of PTK7

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches du Rhone
      • Marseille, Bouches du Rhone, France, 13009
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AML patients at diagnosis
Other: Blood sampling
Other: Bone marrow aspiration

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Norbert Vey, MD, Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAM-PTK7-IPC 2013-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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