SpondyloarthritisORGANOSPANCT06421116
Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis
An observational study of Spondyloarthritis and Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis, Inflammatory Bowel Diseases
- What is being tested?
- Synovial ultrasound-guided biopsy Intestinal biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2024to 31 Dec 2025
- 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
- Adult, Older adult
Study population: Patients affected by Spondyloarthtitis. Controls with inflammatory or non-inflammatory conditions.
Who may be able to join
- More than 18 years of age;
- Ability to understand and sign an informed consent form;
- Clinical indication for intestinal and/or synovial biopsy;
- Only for SpA patients group: meeting ASAS classification criteria.
Who cannot join
- Actively treated cancer;
- Severe comorbidities that, in the investigator\'s opinion, may affect the quality of samples for planned experimental applications;
- Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease;
- Only for patients undergoing a synovial biopsy: septic arthritis.
Trial locations and contacts
1 site in 1 country.
Maria Antonietta D'Agostino, Professor contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, 00168
Maria Antonietta D'Agostino, Professor, +390630157807, mariaantoniettadagostino@policlinicogemelli.it
Maria Antonietta D'Agostino, Professor
About this study
This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.
- Conditions
- Spondyloarthritis, Inflammatory Bowel Diseases
- Being tested
- Synovial ultrasound-guided biopsy Intestinal biopsy
- Medical subject headings
- Spondylarthritis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovial ultrasound-guided biopsy Intestinal biopsyProcedure or surgery
Patients will undergo biopsies if needed for standard-of-care follow-up and after clinical indication.
What is being measured
The primary outcome is the main question the study is designed to answer.
Viability assessment
The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase.
Measured: 24 months
Secondary outcomes (1)
Production of pro-inflammatory cytokines
The production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start7 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421116
- Sponsor's protocol ID
- 6378
- Acronym
- ORGANOSPA
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis
- ClinicalTrials.gov ID
- NCT06421116
- Acronym / sponsor ID
- ORGANOSPA / 6378
- Conditions
- Spondyloarthritis, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 May 2024 (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.
This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients affected by Spondyloarthtitis. Controls with inflammatory or non-inflammatory conditions.
Key inclusion criteria (4 listed)
- More than 18 years of age;
- Ability to understand and sign an informed consent form;
- Clinical indication for intestinal and/or synovial biopsy;
- Only for SpA patients group: meeting ASAS classification criteria.
Key exclusion criteria (4 listed)
- Actively treated cancer;
- Severe comorbidities that, in the investigator\'s opinion, may affect the quality of samples for planned experimental applications;
- Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease;
- Only for patients undergoing a synovial biopsy: septic arthritis.
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 |
|---|---|---|
| Synovial ultrasound-guided biopsy Intestinal biopsyPatients will undergo biopsies if needed for standard-of-care follow-up and after clinical indication. | Procedure or surgery | – |
Primary outcome
Viability assessment
Time frame: 24 months
The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase.
1 secondary outcome
Production of pro-inflammatory cytokines
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
Maria Antonietta D'Agostino, Professor contact
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 Spondyloarthritis and Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Antonietta D'Agostino, Professor (+390630157807, mariaantoniettadagostino@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viability assessment (time frame: 24 months). 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 20 May 2024.