Severe Combined ImmunodeficiencyLymphImagingNCT04246840
Study Through Imaging of Visceral Lymphoid Organs in Patients With SCID Who Have Recieved Bone Marrow Allograft
An observational study of Severe Combined Immunodeficiency, run by Association Pour l'Aide a la Recherche en Immunologie Pediatrique at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Combined Immunodeficiency
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2020to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with SCID transplanted 15-45 years ago and healthy conrtrols
Who may be able to join
- Patients with SCID transplanted 15-45 years ago
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Severe Combined Immunodeficiency
- Medical subject headings
- Severe Combined Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of mediastinal and intraabdominal lymph nodes
analysis by MRI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start13 Jan 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Combined ImmunodeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pour l'Aide a la Recherche en Immunologie Pediatrique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246840
- Sponsor's protocol ID
- AARIP-01
- Acronym
- LymphImaging
- Status last verified
- Jul 2021
- First submitted
- 27 Jan 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34261794
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04246840
- Acronym / sponsor ID
- LymphImaging / AARIP-01
- Conditions
- Severe Combined Immunodeficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Association Pour l'Aide a la Recherche en Immunologie PediatriqueUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SCID transplanted 15-45 years ago and healthy conrtrols
Key inclusion criteria (1 listed)
- Patients with SCID transplanted 15-45 years ago
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Size of mediastinal and intraabdominal lymph nodes
Time frame: 1 year
analysis by MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 34261794Berteloot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Combined Immunodeficiency, run by Association Pour l'Aide a la Recherche en Immunologie Pediatrique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of mediastinal and intraabdominal lymph nodes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04246840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.