Metabolomics; Retinopathy; EtiologyNCT06408571
Study on the Pathogenesis of Retinal Vascular Diseases Based on Body Fluid Metabolomics
An observational study of Metabolomics; Retinopathy; Etiology, run by Zhongnan Hospital at 1 site in China.
Trial summary
Through the analysis of metabolites in body fluids (intraocular fluid, plasma) of patients with retinal vascular diseases (retinal vein occlusion, diabetic retinopathy), the possible pathogenesis of retinal vein occlusion was explored. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolomics; Retinopathy; Etiology
- What is being tested?
- etiology
- How many people
- 3,900 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2023to 30 Dec 2024
- 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 RVO and DR Who were admitted to Zhongnan Hospital of Wuhan University from January 2018 to August 2023 (about 3600 cases)
Who may be able to join
- Age ≥18 years old
- Confirmed diagnosis of retinal vein obstruction and diabetic retinopathy through ophthalmic specialist examination
Who cannot join
- Severe systemic diseases
- Pregnant and lactating patients
Trial locations and contacts
1 site in 1 country.
About this study
Through the analysis of metabolites in body fluids (intraocular fluid, plasma) of patients with retinal vascular diseases (retinal vein occlusion, diabetic retinopathy), the possible pathogenesis of retinal vein occlusion was explored.
Read the detailed description
- Clinical data of patients with RVO and DR Were retrospectively studied to analyze their pathogenesis. 2. Metabolomic studies were conducted on body fluids (intraocular fluid and peripheral blood) of patients with RVO and DR And control group to find out the differences and find new targets for the prevention and treatment of RVO and DR.
- Conditions
- Metabolomics; Retinopathy; Etiology
- Being tested
- etiology
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etiologyOther
As an important part of systems biology, metabolomics mainly detects various metabolites in the sample. Different from nucleic acids, proteins and other biological macromolecules, the relative molecular weight of these metabolites is small, generally within 1000Da, such as amino acids, carboxylic acids, carbohydrates, alcohols, amines, lipids and other special substances. Through qualitative and quantitative analysis of all endogenous low molecular weight metabolites before and after pathophysiology or gene modification stimulation, metabolomics reveals the essential characteristics of life activities and metabolism of the body, and provides guidance for exploring the pathogenesis, early diagnosis, treatment and prognosis of diseases.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients with retinal vein obstruction and diabetic retinopathy Receives: Other: etiology | |
| Control group | Cataract surgery and vitrectomy patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening of prognostic markers and model validation
- Surface markers and key molecules related to the study of diseases were screened out, and a biomarker model for assessing disease prognosis was established.
- Candidate differential molecules were screened through a training cohort, a Cox regression model was constructed, and the prognostic value of the model was verified in the test cohort.
Measured: 1/12/2024-30/12/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start7 Sep 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolomics; Retinopathy; EtiologyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408571
- Sponsor's protocol ID
- 20240202
- Status last verified
- Feb 2024
- First submitted
- 21 Mar 2024
- Last updated
- 10 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Pathogenesis of Retinal Vascular Diseases Based on Body Fluid Metabolomics
- ClinicalTrials.gov ID
- NCT06408571
- Acronym / sponsor ID
- 20240202
- Conditions
- Metabolomics; Retinopathy; Etiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,900 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 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.
Through the analysis of metabolites in body fluids (intraocular fluid, plasma) of patients with retinal vascular diseases (retinal vein occlusion, diabetic retinopathy), the possible pathogenesis of retinal vein occlusion was explored.
Detailed description
- Clinical data of patients with RVO and DR Were retrospectively studied to analyze their pathogenesis. 2. Metabolomic studies were conducted on body fluids (intraocular fluid and peripheral blood) of patients with RVO and DR And control group to find out the differences and find new targets for the prevention and treatment of RVO and DR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: etiologyPatients with retinal vein obstruction and diabetic retinopathy |
| Control group | – | –Cataract surgery and vitrectomy patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RVO and DR Who were admitted to Zhongnan Hospital of Wuhan University from January 2018 to August 2023 (about 3600 cases)
Key inclusion criteria (2 listed)
- Age ≥18 years old
- Confirmed diagnosis of retinal vein obstruction and diabetic retinopathy through ophthalmic specialist examination
Key exclusion criteria (2 listed)
- Severe systemic diseases
- Pregnant and lactating patients
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 |
|---|---|---|
| etiologyAs an important part of systems biology, metabolomics mainly detects various metabolites in the sample. Different from nucleic acids, proteins and other biological macromolecules, the relative molecular weight of these metabolites is small, generally within 1000Da, such as amino acids, carboxylic acids, carbohydrates, alcohols, amines, lipids and other special substances. Through qualitative and quantitative analysis of all endogenous low molecular weight metabolites before and after pathophysiology or gene modification stimulation, metabolomics reveals the essential characteristics of life activities and metabolism of the body, and provides guidance for exploring the pathogenesis, early diagnosis, treatment and prognosis of diseases. | Other | Experimental group |
Primary outcome
Screening of prognostic markers and model validation
Time frame: 1/12/2024-30/12/2024
1. Surface markers and key molecules related to the study of diseases were screened out, and a biomarker model for assessing disease prognosis was established. 2. Candidate differential molecules were screened through a training cohort, a Cox regression model was constructed, and the prognostic value of the model was verified in the test cohort.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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 Metabolomics; Retinopathy; Etiology, run by Zhongnan Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 10 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 China. 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?
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?
Screening of prognostic markers and model validation (time frame: 1/12/2024-30/12/2024). 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 10 May 2024.