NCT06608147

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
103mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Dec 2024Oct 2034

First Submitted

Initial submission to the registry

September 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 4, 2024

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2034

Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

9.8 years

First QC Date

September 19, 2024

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Flow cytometric quantification of cell populations

    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

Study Arms (1)

Experimental

EXPERIMENTAL
Other: Sampling

Interventions

sternal bone marrow aspiration

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)\].

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, 35009, France

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Juliette Ferrant, MD

    CHU Rennes

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 23, 2024

Study Start

December 4, 2024

Primary Completion (Estimated)

October 1, 2034

Study Completion (Estimated)

October 1, 2034

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations