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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02860793
Other study ID # LAM-PTK7-IPC 2013-011
Secondary ID
Status Completed
Phase N/A
First received August 2, 2016
Last updated August 9, 2016
Start date January 2014

Study information

Verified date August 2016
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
Bone marrow aspiration

Blood sampling


Locations

Country Name City State
France Institut Paoli Calmettes Marseille Bouches du Rhone

Sponsors (1)

Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation PTK7+ and PTK7- AML cells hematopoietic homing abilities in xenografted mice by in vivo bioluminescence imaging 1 day No
Primary Soluble PTK7 measurement in the serum 12 years No
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