In Vitro Drug Sensitivity Testing of Fresh Human Samples

NCT ID: NCT05001386

Last Updated: 2022-03-17

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

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2025-03-31

Brief Summary

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Hematological malignancies gather several various pathologies included myeloproliferative disorders (as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML)) and lymphoproliferative disorders (as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)) .

Over the last decade, the treatments have evolved significantly but the overall survival remains limited, especially for the AML and MM patients. There's an ongoing imperative to continue in-vitro and in-vivo studies to better evaluate the anti-cancer drugs sensitivity and therefore improving the response to treatments and open new fields of application. The healthy control group will be contributing to produce some pertinent and significant data for the results of the index cases group.

The investigators aim to analyze 10 differents drugs, common use in chemotherapy or immunotherapy and evaluate by 2 ways the sensitivity: first, Flow cytometry (cells apoptosis by Annexine V and propidium iodide) on fresh samples and in a second time, monitoring of the blasts in the mouse's blood after injection.

Detailed Description

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Conditions

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Myeloproliferative Disorders Lymphoproliferative Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Lymphoproliferative disorders

Patients followed in the haematology unit of Hospices Civils de Lyon for lymproliferative disorders as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) .

Group Type EXPERIMENTAL

Blood collection for the evaluation of the anti-drugs sensitivity

Intervention Type BIOLOGICAL

The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.

Control group

Patients followed in the medicine of aging unit in the Hospices Civils de Lyon without haematological malignancies, without chemotherapy and without immunosuppressive treatment (≤ 5 years)

Group Type SHAM_COMPARATOR

Blood collection for the evaluation of the anti-drugs sensitivity

Intervention Type BIOLOGICAL

The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.

Myeloproliferative disorders

Patients followed in the haematology unit of Hospices Civils de Lyon for myeloproliferative disorders as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML).

Group Type EXPERIMENTAL

Blood collection for the evaluation of the anti-drugs sensitivity

Intervention Type BIOLOGICAL

The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.

Interventions

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Blood collection for the evaluation of the anti-drugs sensitivity

The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Index cases: patients with myeloproliferative or lymphoproliferative disorders.
* Controls: patients without hematological disease, without chemotherapy ((≤ 5 years.) and without immunosuppressive treatment at the study time.
* Age ≥ 18 y.o for all the patients

Exclusion Criteria

* Age \< 18 y.o
* Pregnant or breastfeeding woman
* Patients deprived of their liberty by judicial or administrative decision.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Lyon Sud -Service d'Hématologie

Pierre-Bénite, , France

Site Status

Centre Hospitalier Lyon Sud -Service de médecine du vieillissement

Pierre-Bénite, , France

Site Status

Countries

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France

Central Contacts

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Charles Pr DUMONTET, PhD, MD

Role: CONTACT

0478468340

Marc Pr BONNEFOY, MD

Role: CONTACT

Facility Contacts

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Charles DUMONTET, MD

Role: primary

0478468340

Marc BONNEFOY, MD

Role: primary

0478861580

Other Identifiers

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69HCL21_0622

Identifier Type: -

Identifier Source: org_study_id

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