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

July 24, 2018 updated by: Institut Paoli-Calmettes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

650

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
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli-Calmettes
        • Principal Investigator:
          • Norbert VEY, MD,PhD

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:

  • 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

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: Acute leukemia/myelodysplastic or myeloproliferative disease
Other: Blood sampling
Longitudinal (3 stages of the disease)
Other: Bone marrow aspirate
Longitudinal (3 stages of the disease)
Other: Skin biopsy
Single biopsy (optional)
Other: Buccal swab
Single sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)
Time Frame: up to 8 years
up to 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)
Time Frame: up to 8 years
up to 8 years
Compare cancer and non-tumor cells genome
Time Frame: up to 8 years
up to 8 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,PhD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 1, 2014

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 19, 2014

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMATO-BIO-IPC-2013-015

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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