Lipid PneumoniaNCT06430008
The Relationship Between Total Sialic Acid and Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia
An observational study of Lipid Pneumonia and Superoxide Dismutase, run by Hu Yinan at 1 site in China.
Trial summary
The goal of this observational study is to explore the correlation between total sialic acid combined with superoxide dismutase and the diagnosis and prognosis of lipid pneumonia in the patient with lipid pneumonia, cough, bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipid Pneumonia, Superoxide Dismutase, Sialic Acid
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 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
- Adult, Older adult
Study population: This study includes the lipoid pneumonia patients, patients with cough in the upper respiratory tract only, patients with bacterial and fungal pneumonia, patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis, patients with lung mucinous adenocarcinoma and patients with pulmonary edema.
Who may be able to join
- Age≥ 18 years old;
- The diagnosis of lipoid pneumonia must be supported by lung biopsy pathological support or positive oil red O or Sudan staining in bronchoalveolar lavage fluid;
- Patients with bacterial and fungal pneumonia must be supported by etiological evidence;
- Patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis must be supported by lung biopsy pathology;
- Patients with lung mucinous adenocarcinoma must be supported by lung tissue biopsy;
- Lung imaging of patients with pulmonary edema must show paving stone signs;
Who cannot join
- Age\< 18 years old;
- The patient only has a history of lipid inhalation and no pathology or positive lipoid staining;
- Co-infection with the corona virus disease 2019 at the onset of illness;
- Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: A Study to Explore the Correlation Between Total Sialic Acid Combined With Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia
The goal of this observational study is to explore the correlation between total sialic acid combined with superoxide dismutase and the diagnosis and prognosis of lipid pneumonia in the patient with lipid pneumonia, cough, bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema. The main question it aims to answer is:
Whether superoxide dismutase (SOD) and total sialic acid (TSA) could be used as diagnostic markers to distinguish lipid pneumonia from patient with cough, and bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema, whether SOD and TSA be associated with the prognosis of patients with lipid pneumonia?
Participants will answer online survey questions about their symptoms, changes in oxygen status, and changes in the most recent CT image of the lung for up to 10 years after treatment. We will count participants' baseline data including: gender, age, smoking history, comorbidities, lung function, imaging findings, hormone use or not, ICU treatment, death or not, the type of cause of lipid pneumonia, how it is diagnosed, and their baseline SOD and TSA.
- Conditions
- Lipid Pneumonia, Superoxide Dismutase, Sialic Acid
- Medical subject headings
- Pneumonia, Lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lipid pneumonia | Not described | |
| cough | Not described | |
| cryptogenic organizing pneumonia | Not described | |
| pulmonary alveolar proteinosis | Not described | |
| bacterial pneumonia | Not described | |
| fungal pneumonia | Not described | |
| pulmonary edema | Not described | |
| mucinous adenocarcinoma of the lung | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
superoxide dismutase
Measured: At the time of admission
Secondary outcomes (3)
sialic acid
Measured: At the time of admission
death or not
Measured: Within 10 years after discharge
neutrophil-to-lymphocyte ratio
Measured: At the time of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 May 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Lipid PneumoniaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hu Yinan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hu Yinan, China-Japan Friendship Hospital
- Investigators
- Yinan Hu, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430008
- Sponsor's protocol ID
- 2024-KY-144
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial, only IPD used in the results publication
Publications
Hu Y, Ren Y, Han Y, Li Z, Meng W, Qiang Y, Liu M, Dai H. Relevance of superoxide dismutase type 1 to lipoid pneumonia: the first retrospective case-control study. Respir Res. 2025 Jan 18;26(1):24. doi: 10.1186/s12931-025-03101-3.
PubMed 39827104
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Explore the Correlation Between Total Sialic Acid Combined With Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia
- ClinicalTrials.gov ID
- NCT06430008
- Acronym / sponsor ID
- 2024-KY-144
- Conditions
- Lipid Pneumonia, Superoxide Dismutase, Sialic Acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hu YinanUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 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.
The goal of this observational study is to explore the correlation between total sialic acid combined with superoxide dismutase and the diagnosis and prognosis of lipid pneumonia in the patient with lipid pneumonia, cough, bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema. The main question it aims to answer is:
Whether superoxide dismutase (SOD) and total sialic acid (TSA) could be used as diagnostic markers to distinguish lipid pneumonia from patient with cough, and bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema, whether SOD and TSA be associated with the prognosis of patients with lipid pneumonia?
Participants will answer online survey questions about their symptoms, changes in oxygen status, and changes in the most recent CT image of the lung for up to 10 years after treatment. We will count participants' baseline data including: gender, age, smoking history, comorbidities, lung function, imaging findings, hormone use or not, ICU treatment, death or not, the type of cause of lipid pneumonia, how it is diagnosed, and their baseline SOD and TSA.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| lipid pneumonia | – | – |
| cough | – | – |
| cryptogenic organizing pneumonia | – | – |
| pulmonary alveolar proteinosis | – | – |
| bacterial pneumonia | – | – |
| fungal pneumonia | – | – |
| pulmonary edema | – | – |
| mucinous adenocarcinoma of the lung | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study includes the lipoid pneumonia patients, patients with cough in the upper respiratory tract only, patients with bacterial and fungal pneumonia, patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis, patients with lung mucinous adenocarcinoma and patients with pulmonary edema.
Key inclusion criteria (6 listed)
- Age≥ 18 years old;
- The diagnosis of lipoid pneumonia must be supported by lung biopsy pathological support or positive oil red O or Sudan staining in bronchoalveolar lavage fluid;
- Patients with bacterial and fungal pneumonia must be supported by etiological evidence;
- Patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis must be supported by lung biopsy pathology;
- Patients with lung mucinous adenocarcinoma must be supported by lung tissue biopsy;
Key exclusion criteria (4 listed)
- Age\< 18 years old;
- The patient only has a history of lipid inhalation and no pathology or positive lipoid staining;
- Co-infection with the corona virus disease 2019 at the onset of illness;
- Pregnant
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
superoxide dismutase
Time frame: At the time of admission
3 secondary outcomes
sialic acid
Time frame: At the time of admission
death or not
Time frame: Within 10 years after discharge
neutrophil-to-lymphocyte ratio
Time frame: At the time of admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 39827104Hu Y, Ren Y, Han Y, Li Z, Meng W, Qiang Y, Liu M, Dai H. Relevance of superoxide dismutase type 1 to lipoid pneumonia: the first retrospective case-control study. Respir Res. 2025 Jan 18;26(1):24. doi: 10.1186/s12931-025-03101-3.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial, only IPD used in the results publication
Related trials for Lipid Pneumonia
Enrolling by invitationObservational study
Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections
Sepsis, Infective Endocarditis
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.
Yinan Hu study chair
China-Japan Friendship Hospital
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 Lipid Pneumonia and Superoxide Dismutase, run by Hu Yinan 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 6 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 28 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?
superoxide dismutase (time frame: At the time of admission). 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 NCT06430008, 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 28 May 2024.