NCT04947618

Brief Summary

Observation of a cohort of 400 patients with different types of lymphomas.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
2.6 years until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

June 23, 2021

Last Update Submit

January 23, 2024

Conditions

Keywords

-LymphomaMantle-CellFollicularHodgkinT-cellPrimitive CerebralMarginal ZoneWaldenström's macroglobulinemia

Outcome Measures

Primary Outcomes (6)

  • Overall survival rate among patients with Hodgkin Lymphomas

    The number of months during which the patient has survived since inclusion will be noted. If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.

    2 years after inclusion

  • Overall survival rate among patients with Mantle-cell Lymphomas

    The number of months during which the patient has survived since inclusion will be noted.If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.

    2 years after inclusion

  • Overall survival rate among patients with Primitive Cerebral Lymphomas

    The number of months during which the patient has survived since inclusion will be noted. If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.

    2 years after inclusion

  • Overall survival rate among patients with Follicular Lymphomas

    The number of months during which the patient has survived since inclusion will be noted. If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.

    2 years after inclusion

  • Overall survival rate among patients with Marginal Zone Lymphomas

    The number of months during which the patient has survived since inclusion will be noted. If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.

    2 years after inclusion

  • Overall survival rate among patients with Waldenström's Disease

    If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.

    2 years after inclusion

Secondary Outcomes (18)

  • Differences between management of patients with Hodgkin Lymphomas actually observed and data described in the literature.

    2 years after inclusion

  • Differences between management of patients with Mantle-cell Lymphomas and data described in the literature.

    2 years after inclusion

  • Differences between management of patients with Primitive Cerebral Lymphomas and data described in the literature.

    2 years after inclusion

  • Differences between management of patients with Follicular Lymphomas and data described in the literature.

    2 years after inclusion

  • Differences between management of patients with Marginal Zone Lymphomas and data described in the literature.

    2 years after inclusion

  • +13 more secondary outcomes

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population consists of patients with lymphomas (Malignant Non-Hodgkinien and Hodgkin Lymphomas) diagnosed at Nîmes University Hospital from 1999 onwards and for whom the frozen biological samples are available. Since 2005, all patients have been registered in the Tumototek software program. Those diagnosed before this date can be found in the hospital's anatomopathological laboratory registers.

You may qualify if:

  • Patients over the age of 15 years and 3 months, diagnosed with lymphoma at Nîmes University Hospital as from 1999 onwards and for whom diagnostic tumor material is available.

You may not qualify if:

  • Patients aged 18 or over who have expressed their desire not to take part in the study.
  • Patients under the age of 18 whose legal representatives have expressed their desire for the child not to take part in the study.
  • Patients under legal guardianship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lymphoma protocol was applied. Biopsies of lymphomas used for anatomopathological analysis, frozen and used for cytogenetic analysis if possible.

MeSH Terms

Conditions

LymphomaWaldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Study Officials

  • Anissa MEGZARI

    CHU de Nîmes (Nîmes University Hospital)

    STUDY CHAIR

Central Study Contacts

Eric JOURDAN, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 1, 2021

Study Start

January 22, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations