Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015

NCT ID: NCT02320656

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2024-05-31

Brief Summary

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HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.

HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:

* tumor samples: marrow aspiration, blood sampling.
* non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.

Detailed Description

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Conditions

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Acute Leukemia Myelodysplastic Syndromes Myeloproliferative Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Acute leukemia/myelodysplastic or myeloproliferative disease

Group Type EXPERIMENTAL

Blood sampling

Intervention Type OTHER

Longitudinal (3 stages of the disease)

Bone marrow aspirate

Intervention Type OTHER

Longitudinal (3 stages of the disease)

Skin biopsy

Intervention Type OTHER

Single biopsy (optional)

Buccal swab

Intervention Type OTHER

Single sampling.

Interventions

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Blood sampling

Longitudinal (3 stages of the disease)

Intervention Type OTHER

Bone marrow aspirate

Longitudinal (3 stages of the disease)

Intervention Type OTHER

Skin biopsy

Single biopsy (optional)

Intervention Type OTHER

Buccal swab

Single sampling.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* acute leukemia, myelodysplastic syndrome or myeloproliferative disease
* age \> 18
* affiliated to the French Social Security Systm
* signed informed consent

Exclusion Criteria

* emergency
* patients deprived of liberty or placed under the authority of a tutor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norbert Vey, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut Paoli-Calmettes

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique Genre, MD

Role: CONTACT

+33491223778

Jihane Pakradouni, PharmD,PhD

Role: CONTACT

+33491223778

References

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Grenier JMP, Testut C, Bal M, Bardin F, De Grandis M, Gelsi-Boyer V, Vernerey J, Delahaye M, Granjeaud S, Zemmour C, Spinella JF, Chavakis T, Mancini SJC, Boher JM, Hebert J, Sauvageau G, Vey N, Schwaller J, Hospital MA, Fauriat C, Aurrand-Lions M. Genetic deletion of JAM-C in preleukemic cells rewires leukemic stem cell gene expression program in AML. Blood Adv. 2024 Sep 10;8(17):4662-4678. doi: 10.1182/bloodadvances.2023011747.

Reference Type DERIVED
PMID: 38954834 (View on PubMed)

Chretien AS, Devillier R, Granjeaud S, Cordier C, Demerle C, Salem N, Wlosik J, Orlanducci F, Gorvel L, Fattori S, Hospital MA, Pakradouni J, Gregori E, Paul M, Rochigneux P, Pagliardini T, Morey M, Fauriat C, Dulphy N, Toubert A, Luche H, Malissen M, Blaise D, Nunes JA, Vey N, Olive D. High-dimensional mass cytometry analysis of NK cell alterations in AML identifies a subgroup with adverse clinical outcome. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2020459118. doi: 10.1073/pnas.2020459118.

Reference Type DERIVED
PMID: 34050021 (View on PubMed)

Other Identifiers

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HEMATO-BIO-IPC-2013-015

Identifier Type: -

Identifier Source: org_study_id

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