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LymphImaging: Study Through Imaging of Visceral Lymphoid Organs in Patients With SCID Who Have Recieved Bone Marrow Allograft

Sponsor
Association Pour l'Aide a la Recherche en Immunologie Pediatrique (Other)
Overall Status
Completed
CT.gov ID
NCT04246840
Collaborator
(none)
18
Enrollment
1
Location
13.1
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the presence of seconday of lymphoid organs in patients who underwent allogenic hematopoietic stem cell transplantation 15 to 45 years ago.

The goal aims to assess the development of seconday lymphoid organs given the fact that the absence of myeloablation these patients present a split chimerism between T lymphocytes and the other leucocytes. Thus, they may not be able to generate seconday lymphoid organs. Practically, whole body MRI is being used to visualise and quantify both mediastinal and intraabdominal lymph nodes. Delta will be compared with those obtained in healthy age-matched individuals. It is scheduled to include 15 patients and 15 controls.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    18 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Study Through Imaging of Mediastinal and Abdominopelvic Secondary Lymphoid Organs (Lymph Nodes) in Patients With Severe Combined Immunodeficiencies (SCID) Who Have Recieved Bone Narrow Allograft
    Actual Study Start Date :
    Jan 13, 2020
    Actual Primary Completion Date :
    Feb 15, 2021
    Actual Study Completion Date :
    Feb 15, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Study group

    15 adult patients who underwent allogenic hematopoietic stem cell transplantation (HSCT) for severe combined immunodeficieny 15 to 45 years ago
    Control group

    15 age-matched healthy individuals

    Outcome Measures

    Primary Outcome Measures

    1. Size of mediastinal and intraabdominal lymph nodes [1 year]

      analysis by MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with SCID transplanted 15-45 years ago
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Necker Paris France

    Sponsors and Collaborators

    • Association Pour l'Aide a la Recherche en Immunologie Pediatrique

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Association Pour l'Aide a la Recherche en Immunologie Pediatrique
    ClinicalTrials.gov Identifier:
    NCT04246840
    Other Study ID Numbers:
    • AARIP-01
    First Posted:
    Jan 29, 2020
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Severe Combined Immunodeficiency
    Immunologic Deficiency Syndromes

    Study Results

    No Results Posted as of Jul 22, 2021