NCT04246840

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 13, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

January 27, 2020

Last Update Submit

July 21, 2021

Conditions

Severe Combined Immunodeficiency

Outcome Measures

Primary Outcomes (1)

  • Size of mediastinal and intraabdominal lymph nodes

    analysis by MRI

    1 year

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with SCID transplanted 15-45 years ago and healthy conrtrols

You may qualify if:

  • Patients with SCID transplanted 15-45 years ago

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker

Paris, France

Location

Related Publications (1)

  • Berteloot L, Molina TJ, Bruneau J, Picard C, Barlogis V, Secq V, Abdo C, Boddaert N, Griscelli C, Neven B, Fischer A. Alternative pathways for the development of lymphoid structures in humans. Proc Natl Acad Sci U S A. 2021 Jul 20;118(29):e2108082118. doi: 10.1073/pnas.2108082118.

    PMID: 34261794DERIVED

MeSH Terms

Conditions

Severe Combined Immunodeficiency

Condition Hierarchy (Ancestors)

Primary Immunodeficiency DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 29, 2020

Study Start

January 13, 2020

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

FR(1)