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

Primary Purpose

Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sampling

Bone marrow aspirate

Skin biopsy

Buccal swab

About this trial

This is an interventional basic science trial for Acute Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Paoli-CalmettesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute leukemia/myelodysplastic or myeloproliferative disease

Arm Description

Outcomes

Primary Outcome Measures

Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)

Secondary Outcome Measures

Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)

Compare cancer and non-tumor cells genome

Full Information

NCT ID

NCT02320656

First Posted

December 5, 2014

Last Updated

July 24, 2018

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT02320656

Brief Title

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

Acronym

HEMATO-BIO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Recruiting

Study Start Date

May 2014 (Actual)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders

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

650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acute leukemia/myelodysplastic or myeloproliferative disease

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Blood sampling

Intervention Description

Longitudinal (3 stages of the disease)

Intervention Type

Other

Intervention Name(s)

Bone marrow aspirate

Intervention Description

Longitudinal (3 stages of the disease)

Intervention Type

Other

Intervention Name(s)

Skin biopsy

Intervention Description

Single biopsy (optional)

Intervention Type

Other

Intervention Name(s)

Buccal swab

Intervention Description

Single sampling.

Primary Outcome Measure Information:

Title

Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)

Time Frame

up to 8 years

Secondary Outcome Measure Information:

Title

Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)

Time Frame

up to 8 years

Title

Compare cancer and non-tumor cells genome

Time Frame

up to 8 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominique Genre, MD

Phone

+33491223778

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Jihane Pakradouni, PharmD,PhD

Phone

+33491223778

drci.up@ipc.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norbert Vey, MD,PhD

Organizational Affiliation

Institut Paoli-Calmettes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Paoli-Calmettes

City

Marseille

ZIP/Postal Code

13009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Norbert VEY, MD,PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34050021

Citation

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.

Results Reference

derived

Learn more about this trial

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

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