## Protocol Section
### Identification Module
**NCT ID:** NCT06430008

**Brief Title:** The Relationship Between Total Sialic Acid and Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia

**Official Title:** A Study to Explore the Correlation Between Total Sialic Acid Combined With Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia

#### Organization Study ID Info
**ID:** 2024-KY-144
#### Organization
**Class:** OTHER
**Full Name:** China-Japan Friendship Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hu Yinan

#### Responsible Party

**Investigator Affiliation:** China-Japan Friendship Hospital

**Investigator Full Name:** Hu Yinan

**Investigator Title:** China-Japan Friendship Hospital

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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 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 Module

**Conditions:**

- Lipid Pneumonia

- Superoxide Dismutase

- Sialic Acid

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 160

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** lipid pneumonia

#### Arm Group 2

**Label:** cough

#### Arm Group 3

**Label:** cryptogenic organizing pneumonia

#### Arm Group 4

**Label:** pulmonary alveolar proteinosis

#### Arm Group 5

**Label:** bacterial pneumonia

#### Arm Group 6

**Label:** fungal pneumonia

#### Arm Group 7

**Label:** pulmonary edema

#### Arm Group 8

**Label:** mucinous adenocarcinoma of the lung

### Outcomes Module

#### Primary Outcomes

**Measure:** superoxide dismutase

**Time Frame:** At the time of admission

#### Secondary Outcomes

**Measure:** sialic acid

**Time Frame:** At the time of admission

**Measure:** death or not

**Time Frame:** Within 10 years after discharge

**Measure:** neutrophil-to-lymphocyte ratio

**Time Frame:** At the time of admission

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age≥ 18 years old;
2. 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;
3. Patients with bacterial and fungal pneumonia must be supported by etiological evidence;
4. Patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis must be supported by lung biopsy pathology;
5. Patients with lung mucinous adenocarcinoma must be supported by lung tissue biopsy;
6. Lung imaging of patients with pulmonary edema must show paving stone signs;

Exclusion Criteria:

1. Age\&lt; 18 years old;
2. The patient only has a history of lipid inhalation and no pathology or positive lipoid staining;
3. Co-infection with the corona virus disease 2019 at the onset of illness;
4. Pregnant

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** China-Japan Friendship Hospital

**State:** Beijing

**Zip:** 100000

#### Overall Officials

**Official 1:**

**Affiliation:** China-Japan Friendship Hospital

**Name:** Yinan Hu

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** All IPD collected throughout the trial, only IPD used in the results publication

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**URL:** http://www.medresman.org.cn

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000011015

- Term: Pneumonia, Aspiration

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M13904

- Name: Pneumonia

- Relevance: HIGH

- As Found: Pneumonia

- ID: M13907

- Name: Pneumonia, Lipid

- Relevance: HIGH

- As Found: Lipoid Pneumonia

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13905

- Name: Pneumonia, Aspiration

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011014

- Term: Pneumonia

- ID: D000011017

- Term: Pneumonia, Lipid

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16264

- Name: Superoxide Dismutase

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
