Acute Respiratory Distress Syndrome (ARDS)NCT07129330
RSPO3/SDC-1 Pathway Dysfunction in Alveolar Repair After ARDS in Older Adults
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Age-related Impaired Alveolar Epithelial Repair, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is a serious lung condition in which fluid builds up in the air sacs, making it hard to breathe and often requiring intensive care. Older adults fare worse because their lung-lining cells lose the ability to heal properly after injury This study will explore two key… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Age-related Impaired Alveolar Epithelial Repair
- What is being tested?
- RSPO3/SDC-1 pathway profiling assay and Blood and Saliva
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: ARDS Group: 500 adult patients with acute respiratory distress syndrome, enrolled across five age brackets (20-30, 30-40, 50-60, 70-80, and > 80 years), with 100 participants per stratum Lung Resection Control Group: 500 patients undergoing elective lobectomy for non-infectious pulmonary conditions (e.g., lung tumors, interstitial lung disease), matched by age bracket and size to the ARDS cohort
Who may be able to join
- Clinical diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition Age ≥ 65 years at enrollment First diagnosis of ARDS made within 24 hours prior to study entry Receiving either spontaneous (non-invasive) breathing support or invasive mechanical ventilation
Who cannot join
- Coexisting severe cardiac, hepatic or renal failure (NYHA Class III-IV) Active pulmonary infection (e.g. pneumonia or lung abscess) Significant coagulation disorders Receipt of any cytokine-based therapy within the past 3 months Participation in another interventional clinical study within the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Xinhua hospital
Shanghai
Jiang, +86 13817719616, jianglaimz@sina.com
About this study
Official title: Role and Mechanisms of RSPO3/SDC-1 Pathway Dysregulation in Impaired Alveolar Epithelial Repair Post-ARDS in Older Adults
Acute respiratory distress syndrome (ARDS) is a serious lung condition in which fluid builds up in the air sacs, making it hard to breathe and often requiring intensive care. Older adults fare worse because their lung-lining cells lose the ability to heal properly after injury This study will explore two key molecules-RSPO3 and Syndecan-1 (SDC-1)-that normally help alveolar (air-sac) cells regenerate. We will collect small blood samples from ARDS patients and, when patients undergo elective lung surgery, tiny pieces of healthy lung tissue. In the lab, we will also grow three-dimensional "lung organoids" from these samples to see how boosting or blocking RSPO3/SDC-1 affects cell repair
Our goals are to:
Read more
Measure RSPO3/SDC-1 activity alongside inflammatory markers (e.g., IL-6, TNF-α) to understand their roles in age-related repair failure.
Build an integrated platform for early diagnosis, disease monitoring, and treatment evaluation in older ARDS patients.
Identify molecular targets that could lead to new therapies, helping older adults recover lung function more effectively.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Age-related Impaired Alveolar Epithelial Repair
- Being tested
- RSPO3/SDC-1 pathway profiling assay, Blood and Saliva
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSPO3/SDC-1 pathway profiling assayProcedure or surgery
Peripheral Blood: 5 mL collected into EDTA tubes; PBMCs isolated within 2 h for RT-qPCR analysis of RSPO3/SDC-1 mRNA and sandwich ELISA quantification of protein levels.
Saliva: 2-3 mL unstimulated saliva naturally expectorated into sterile tubes, kept at 4 °C and processed within 2 h (centrifuged, aliquoted) before -80 °C storage Subcutaneous Fat: 100-200 mg obtained during elective procedures, preserved in RNAlater at 4 °C for 24 h, then frozen at -80 °C 3D Alveolar Organoid Assay: Lung tissue-derived organoids are cultured in Matrigel and treated ex vivo with recombinant RSPO3 or SDC-1 neutralizing antibody; epithelial repair is assessed over 7 days by Ki-67 immunostaining and wound-closure measurement
Blood and SalivaProcedure or surgery
Peripheral Blood: 5 mL collected into EDTA tubes; PBMCs isolated within 2 h for RT-qPCR analysis of RSPO3/SDC-1 mRNA and sandwich ELISA quantification of protein levels.
Saliva: 2-3 mL unstimulated saliva naturally expectorated into sterile tubes, kept at 4 °C and processed within 2 h (centrifuged, aliquoted) before -80 °C storage
| Study group | Role | What they receive |
|---|---|---|
| ARDS | Not described Receives: Procedure: Blood and Saliva | |
| NON_ARDS | Not described Receives: Procedure: Blood and Saliva | |
| AGED | Not described Receives: Procedure: RSPO3/SDC-1 pathway profiling assay | |
| YOUNG | Not described Receives: Procedure: RSPO3/SDC-1 pathway profiling assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Peripheral Blood RSPO3/SDC-1 Pathway Activity and Alveolar Epithelial Injury Marker Levels
Quantify RSPO3 and Syndecan-1 expression in peripheral blood (by RT-qPCR and ELISA) and measure alveolar injury biomarkers (SP-A, SP-D) in serum. Calculate Pearson or Spearman correlation coefficients between RSPO3/SDC-1 levels and SP-A/SP-D concentrations in elderly ARDS patients at baseline.
Measured: Baseline (within 24 hours of ARDS diagnosis)
Secondary outcomes (1)
Effect of RSPO3/SDC-1 Pathway Modulation on Alveolar Organoid Repair Capacity
Assess lung organoid epithelial repair by measuring (1) percentage of Ki-67-positive cells and (2) wound-closure area in 3D alveolar organoid cultures treated with recombinant RSPO3 protein or SDC-1 neutralizing antibody versus untreated controls.
Measured: Within 14 days of organoid establishment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai Jiang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129330
- Sponsor's protocol ID
- XHEC-C-2025-167-1
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Mechanisms of RSPO3/SDC-1 Pathway Dysregulation in Impaired Alveolar Epithelial Repair Post-ARDS in Older Adults
- ClinicalTrials.gov ID
- NCT07129330
- Acronym / sponsor ID
- XHEC-C-2025-167-1
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Age-related Impaired Alveolar Epithelial Repair
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 19 Aug 2025 (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.
Acute respiratory distress syndrome (ARDS) is a serious lung condition in which fluid builds up in the air sacs, making it hard to breathe and often requiring intensive care. Older adults fare worse because their lung-lining cells lose the ability to heal properly after injury This study will explore two key molecules-RSPO3 and Syndecan-1 (SDC-1)-that normally help alveolar (air-sac) cells regenerate. We will collect small blood samples from ARDS patients and, when patients undergo elective lung surgery, tiny pieces of healthy lung tissue. In the lab, we will also grow three-dimensional "lung organoids" from these samples to see how boosting or blocking RSPO3/SDC-1 affects cell repair
Our goals are to:
Measure RSPO3/SDC-1 activity alongside inflammatory markers (e.g., IL-6, TNF-α) to understand their roles in age-related repair failure.
Build an integrated platform for early diagnosis, disease monitoring, and treatment evaluation in older ARDS patients.
Identify molecular targets that could lead to new therapies, helping older adults recover lung function more effectively.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARDS | – | Procedure: Blood and Saliva |
| NON_ARDS | – | Procedure: Blood and Saliva |
| AGED | – | Procedure: RSPO3/SDC-1 pathway profiling assay |
| YOUNG | – | Procedure: RSPO3/SDC-1 pathway profiling assay |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ARDS Group: 500 adult patients with acute respiratory distress syndrome, enrolled across five age brackets (20-30, 30-40, 50-60, 70-80, and > 80 years), with 100 participants per stratum Lung Resection Control Group: 500 patients undergoing elective lobectomy for non-infectious pulmonary conditions (e.g., lung tumors, interstitial lung disease), matched by age bracket and size to the ARDS cohort
Key inclusion criteria (1 listed)
- Clinical diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition Age ≥ 65 years at enrollment First diagnosis of ARDS made within 24 hours prior to study entry Receiving either spontaneous (non-invasive) breathing support or invasive mechanical ventilation
Key exclusion criteria (1 listed)
- Coexisting severe cardiac, hepatic or renal failure (NYHA Class III-IV) Active pulmonary infection (e.g. pneumonia or lung abscess) Significant coagulation disorders Receipt of any cytokine-based therapy within the past 3 months Participation in another interventional clinical study within the past 3 months
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 |
|---|---|---|
| RSPO3/SDC-1 pathway profiling assayPeripheral Blood: 5 mL collected into EDTA tubes; PBMCs isolated within 2 h for RT-qPCR analysis of RSPO3/SDC-1 mRNA and sandwich ELISA quantification of protein levels. Saliva: 2-3 mL unstimulated saliva naturally expectorated into sterile tubes, kept at 4 °C and processed within 2 h (centrifuged, aliquoted) before -80 °C storage Subcutaneous Fat: 100-200 mg obtained during elective procedures, preserved in RNAlater at 4 °C for 24 h, then frozen at -80 °C 3D Alveolar Organoid Assay: Lung tissue-derived organoids are cultured in Matrigel and treated ex vivo with recombinant RSPO3 or SDC-1 neutralizing antibody; epithelial repair is assessed over 7 days by Ki-67 immunostaining and wound-closure measurement | Procedure or surgery | AGED, YOUNG |
| Blood and SalivaPeripheral Blood: 5 mL collected into EDTA tubes; PBMCs isolated within 2 h for RT-qPCR analysis of RSPO3/SDC-1 mRNA and sandwich ELISA quantification of protein levels. Saliva: 2-3 mL unstimulated saliva naturally expectorated into sterile tubes, kept at 4 °C and processed within 2 h (centrifuged, aliquoted) before -80 °C storage | Procedure or surgery | ARDS, NON_ARDS |
Primary outcome
Correlation Between Peripheral Blood RSPO3/SDC-1 Pathway Activity and Alveolar Epithelial Injury Marker Levels
Time frame: Baseline (within 24 hours of ARDS diagnosis)
Quantify RSPO3 and Syndecan-1 expression in peripheral blood (by RT-qPCR and ELISA) and measure alveolar injury biomarkers (SP-A, SP-D) in serum. Calculate Pearson or Spearman correlation coefficients between RSPO3/SDC-1 levels and SP-A/SP-D concentrations in elderly ARDS patients at baseline.
1 secondary outcome
Effect of RSPO3/SDC-1 Pathway Modulation on Alveolar Organoid Repair Capacity
Time frame: Within 14 days of organoid establishment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingObservational study
Right Heart Injury Monitoring on ECMO
Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF)
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.
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 Acute Respiratory Distress Syndrome (ARDS) and Age-related Impaired Alveolar Epithelial Repair, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 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: opening soon, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang (+86 13817719616, jianglaimz@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Peripheral Blood RSPO3/SDC-1 Pathway Activity and Alveolar Epithelial Injury Marker Levels (time frame: Baseline (within 24 hours of ARDS diagnosis)). 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 19 Aug 2025.