TonsillectomyLINKNCT03311919
Exploratory Study of "Natural Killer" Inflammatory Lymphocytes in Waste Per-operating of Tonsillectomy
An observational study of Tonsillectomy, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The aim of this study is to describe the frequency of the presence of cells Natural Killer (NK) expressing CD86 and HLA - DR in tonsils Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tonsillectomy
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to 31 Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient with tonsillectomy
Who may be able to join
- patient with programmed tonsillectomy as part of the care
Who cannot join
- patient opposition to use its waste of per-operating tonsillectomy for research purposes
- patient with immunosuppressive and/or corticoid treatment (> 1 mg/kg)
About this study
The aim of this study is to describe the frequency of the presence of cells Natural Killer (NK) expressing CD86 and HLA - DR in tonsils
- Conditions
- Tonsillectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of lymphocytes NK expressing CD86 and HLA - DR
by immunostaining and detection by flow cytometry
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study startJan 2014
- Primary completionMay 2014
- Study completion31 Dec 2014
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 TonsillectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311919
- Sponsor's protocol ID
- P/2013/204
- Acronym
- LINK
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loyon R, Picard E, Mauvais O, Queiroz L, Mougey V, Pallandre JR, Galaine J, Mercier-Letondal P, Kellerman G, Chaput N, Wijdenes J, Adotevi O, Ferrand C, Romero P, Godet Y, Borg C. IL-21-Induced MHC Class II+ NK Cells Promote the Expansion of Human Uncommitted CD4+ Central Memory T Cells in a Macrophage Migration Inhibitory Factor-Dependent Manner. J Immunol. 2016 Jul 1;197(1):85-96. doi: 10.4049/jimmunol.1501147. Epub 2016 May 27.
PubMed 27233967
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of "Natural Killer" Inflammatory Lymphocytes in Waste Per-operating of Tonsillectomy
- ClinicalTrials.gov ID
- NCT03311919
- Acronym / sponsor ID
- LINK / P/2013/204
- Conditions
- Tonsillectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 17 Oct 2017 (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.
The aim of this study is to describe the frequency of the presence of cells Natural Killer (NK) expressing CD86 and HLA - DR in tonsils
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient with tonsillectomy
Key inclusion criteria (1 listed)
- patient with programmed tonsillectomy as part of the care
Key exclusion criteria (2 listed)
- patient opposition to use its waste of per-operating tonsillectomy for research purposes
- patient with immunosuppressive and/or corticoid treatment (> 1 mg/kg)
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
presence of lymphocytes NK expressing CD86 and HLA - DR
Time frame: inclusion
by immunostaining and detection by flow cytometry
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 17 Oct 2017.
- Background: PubMed 27233967Loyon R, Picard E, Mauvais O, Queiroz L, Mougey V, Pallandre JR, Galaine J, Mercier-Letondal P, Kellerman G, Chaput N, Wijdenes J, Adotevi O, Ferrand C, Romero P, Godet Y, Borg C. IL-21-Induced MHC Class II+ NK Cells Promote the Expansion of Human Uncommitted CD4+ Central Memory T Cells in a Macrophage Migration Inhibitory Factor-Dependent Manner. J Immunol. 2016 Jul 1;197(1):85-96. doi: 10.4049/jimmunol.1501147. Epub 2016 May 27.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillectomy, run by Centre Hospitalier Universitaire de Besancon.
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 2 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 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
presence of lymphocytes NK expressing CD86 and HLA - DR (time frame: inclusion). 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 NCT03311919, 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 17 Oct 2017.