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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02320656
Acronym
HEMATO-BIO
Enrollment
650
Registered
2014-12-19
Start date
2014-05-31
Completion date
2024-05-31
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders

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.

Interventions

OTHERBlood sampling

Longitudinal (3 stages of the disease)

OTHERBone marrow aspirate

Longitudinal (3 stages of the disease)

OTHERSkin biopsy

Single biopsy (optional)

Single sampling.

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)up to 8 years

Secondary

MeasureTime frame
Compare cancer and non-tumor cells genomeup to 8 years
Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)up to 8 years

Countries

France

Contacts

Primary ContactDominique Genre, MD
drci.up@ipc.unicancer.fr+33491223778
Backup ContactJihane Pakradouni, PharmD,PhD
drci.up@ipc.unicancer.fr+33491223778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026