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

• Sponsor: Institut Paoli-Calmettes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02320656
• Collaborator: (none)
• Enrollment: 650
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 5.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Leukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders	Other: Blood sampling; Other: Bone marrow aspirate; Other: Skin biopsy; Other: Buccal swab	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 650 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
• Actual Study Start Date: May 1, 2014
• Anticipated Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping) [up to 8 years]

Secondary Outcome Measures

1. Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival) [up to 8 years]

2. Compare cancer and non-tumor cells genome [up to 8 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Paoli-Calmettes	Marseille		France	13009

Sponsors and Collaborators

• Institut Paoli-Calmettes

Investigators

• Principal Investigator: Norbert Vey, MD,PhD, Institut Paoli-Calmettes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Paoli-Calmettes
• ClinicalTrials.gov Identifier: NCT02320656
• Other Study ID Numbers: HEMATO-BIO-IPC-2013-015
• First Posted: Dec 19, 2014
• Last Update Posted: Jul 26, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Syndrome; Acute Disease

Study Results

No Results Posted as of Jul 26, 2018