Scleroderma, SystemicDig-ScSNCT04148716
microRNAs in Systemic Scleroderma
An observational study of Scleroderma, Systemic, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
No studies have investigated the expression of miRNAs in Dig-ScS tissues. In the absence of specific treatment for this frequent impairment in this connectivity, the team proposes to study miRNA profiles in the esophagus and duodenum to identify new therapeutic targets. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- additional biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2021to 22 Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people needed esogastro-duodenal fibroscopy
Who may be able to join
None listed.
Who cannot join
- Subject protected by law under guardianship or curatorship, or unable to participate in a clinical study under Article L. 1121-16 of the French Public Health Code
- Subject who has participated in a clinical research study in the last 3 months in which he/she was exposed to a pharmaceutical product or medical device
- Subject who has stayed in a tropical or subtropical country in the last 3 months
- Pregnant or breastfeeding participant
- Subject on a special diet for medical reasons and prescribed by a doctor or dietician (e.g. a low-calorie diet or a diet designed to lower cholesterol levels)
- Subject who regularly consumes large quantities of alcohol, i. e. more than 50 g of pure alcohol per day (e. g. more than 4 glasses of 150 ml wine, more than 4 pints of 250 ml beer, or more than 4 glasses of 40 ml containing strong alcohol)
Show all 20Show fewer
- Subject who has used an illegal recreational drug in the past 3 months
- Subject who has taken an immunosuppressive or immunomodulatory drug (excluding corticosteroids administered at doses ≤ 10 mg/d PREDNISONE equivalent) within the previous 2 weeks, or for more than 14 consecutive days within the last 3 months
- Subject who has been vaccinated within the last 3 months
- Subject who received a blood transfusion or immunoglobulins in the last 3 months
- Subject stating that he has not been fasting for at least 10 hours
- Subject reporting HIV or HCV status
- Subject who had an infectious episode or was treated with antibiotics during the 4 weeks prior to the visit
- Subject with a positive pregnancy test
- Subject with graft versus host disease, or who has received therapy involving hematopoietic stem cells
- Subject with a severe and/or chronic and/or recurrent pathology, in particular:
- A chronic inflammatory disease of the intestine (Crohn's disease, ulcerative colitis), epidermis (psoriasis, atopic dermatitis), joints (rheumatoid arthritis), nervous system (multiple sclerosis); except ScS.
- A neurodegenerative disease
- Diabetes mellitus
- Subject who has been diagnosed with cancer and has not been in remission for more than 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Characterization of microRNAs Involved in Esophageal, Gastric and Duodenal Fibrotic Manifestations of Systemic Scleroderma
No studies have investigated the expression of miRNAs in Dig-ScS tissues. In the absence of specific treatment for this frequent impairment in this connectivity, the team proposes to study miRNA profiles in the esophagus and duodenum to identify new therapeutic targets. The team is studying the involvement of pro-fibrotic "key" miRNAs called "FibromiRs", including 3 miRNAs from the DNM3os locus (miR-199a-3p, miR-199a-5p and miR-214 - characterized by the host laboratory) associated with monitoring the response to TGF-β in fibroblasts and their potential interaction with pharmacological treatments such as nintedanib and/or PPARγ agonists. The approach is part of a pilot study that can lead to a larger project after validation of the hypotheses.
It also seems interesting to make a precise anatomopathological description with a gradation of the digestive fibrotic damage in view of the paucity of medical literature in this field
- Conditions
- Scleroderma, Systemic
- Being tested
- additional biopsies
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional biopsiesProcedure or surgery
additional biopsies during a fibroscopy planned in the care
| Study group | Role | What they receive |
|---|---|---|
| patients | recruitement of 9 patients Receives: Procedure: additional biopsies | |
| control | recruitement of 9 control person Receives: Procedure: additional biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of the profile of miR based expression on cytokinic treatments and stimuli.
fundamental research aimed at determining an expression profile of miR as a function of cytokinic treatments and stimuli. proteins (cytokins) study to describe the profil of miR
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start11 Jan 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148716
- Sponsor's protocol ID
- 19-AOI-07
- Acronym
- Dig-ScS
- Status last verified
- Jun 2024
- First submitted
- 25 Oct 2019
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of microRNAs Involved in Esophageal, Gastric and Duodenal Fibrotic Manifestations of Systemic Scleroderma
- ClinicalTrials.gov ID
- NCT04148716
- Acronym / sponsor ID
- Dig-ScS / 19-AOI-07
- Conditions
- Scleroderma, Systemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 1 Nov 2019 (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.
No studies have investigated the expression of miRNAs in Dig-ScS tissues. In the absence of specific treatment for this frequent impairment in this connectivity, the team proposes to study miRNA profiles in the esophagus and duodenum to identify new therapeutic targets. The team is studying the involvement of pro-fibrotic "key" miRNAs called "FibromiRs", including 3 miRNAs from the DNM3os locus (miR-199a-3p, miR-199a-5p and miR-214 - characterized by the host laboratory) associated with monitoring the response to TGF-β in fibroblasts and their potential interaction with pharmacological treatments such as nintedanib and/or PPARγ agonists. The approach is part of a pilot study that can lead to a larger project after validation of the hypotheses.
It also seems interesting to make a precise anatomopathological description with a gradation of the digestive fibrotic damage in view of the paucity of medical literature in this field
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Procedure: additional biopsiesrecruitement of 9 patients |
| control | – | Procedure: additional biopsiesrecruitement of 9 control person |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people needed esogastro-duodenal fibroscopy
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Subject protected by law under guardianship or curatorship, or unable to participate in a clinical study under Article L. 1121-16 of the French Public Health Code
- Subject who has participated in a clinical research study in the last 3 months in which he/she was exposed to a pharmaceutical product or medical device
- Subject who has stayed in a tropical or subtropical country in the last 3 months
- Pregnant or breastfeeding participant
- Subject on a special diet for medical reasons and prescribed by a doctor or dietician (e.g. a low-calorie diet or a diet designed to lower cholesterol levels)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional biopsiesadditional biopsies during a fibroscopy planned in the care | Procedure or surgery | control, patients |
Primary outcome
description of the profile of miR based expression on cytokinic treatments and stimuli.
Time frame: 4 years
fundamental research aimed at determining an expression profile of miR as a function of cytokinic treatments and stimuli. proteins (cytokins) study to describe the profil of miR
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 27 Jun 2024.
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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 Scleroderma, Systemic, run by Centre Hospitalier Universitaire de Nice 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 0 inclusion and 20 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 27 Jun 2024. 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?
description of the profile of miR based expression on cytokinic treatments and stimuli. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2024.