NCT02860793

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

August 2, 2016

Last Update Submit

August 9, 2016

Conditions

Acute Myeloid Leukemia

Keywords

PTK7Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

AML patients at diagnosis

EXPERIMENTAL
Other: Bone marrow aspirationOther: Blood sampling

Interventions

Bone marrow aspirationOTHER
AML patients at diagnosis
Blood samplingOTHER
AML patients at diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches du Rhone, 13009, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Norbert VEY, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 9, 2016

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)