MOLyF : Bone Marrow and Follicular Lymphoma (MOLyF)

December 5, 2024 updated by: Rennes University Hospital

Bone Marrow and Follicular Lymphoma

This is a prospective single-center study designed to assess potential differences in cell composition between bone marrows of patients with follicular lymphoma and those from control subjects.

Follicular lymphoma is the most common indolent lymphoma. It is characterised by systematic relapses and bone marrow dissemination in 70% of patients at the time of diagnosis.

Although relapses are thought to be related to refractory tumour cells nested in a supportive microenvironment in the bone marrow, the mechanisms involved are poorly understood.

To study the specificities of the bone marrow of patients with follicular lymphoma, It is necessary to compare them with control samples.

This study takes advantage of surgeries involving sternotomies to recover lost bone marrow and establish a bone marrow bank of patients without hematological disease.

This bank will be used to set up control cohorts for other clinical trials involving patients with follicular lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Contact Backup

Study Locations

  • France
      • Rennes, France, 35009
        • Recruiting
        • Chu Rennes
        • Contact:
        • Principal Investigator:
          • Juliette Ferrant, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Major patient
  • Patient hospitalized in the thoracic, cardiac and vascular surgery department for surgery involving a sternotomy
  • Patient with free, informed, written consent
  • Patient covered by a health insurance scheme

Exclusion Criteria:

  • History of haematological malignancy or haemogram disturbance
  • Immunomodulating treatment: immunosuppressants, corticoids, antineoplastics
  • Persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.)].

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: Experimental
Other: Sampling
sternal bone marrow aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow cytometric quantification of cell populations
Time Frame: 1 day
Bone marrow cell populations of lymphoma-free patients (lymphoid cells, myeloid cells, stromal cells and adventitial cells) will be quantified using a flow cytometry panel and compared with those of Follicular Lymphoma patients.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Study Chair: Juliette Ferrant, MD, Chu Rennes

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)

December 4, 2024

Primary Completion (Estimated)

October 1, 2034

Study Completion (Estimated)

October 1, 2034

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC24_9716_MOLyF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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