Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04516577 |
| Other study ID # |
2020073195 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Shanghai Pulmonary Hospital, Shanghai, China |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
By updating the chest HRCT scoring criteria of patients with pulmonary alveolar proteinosis,
a new and more perfect system for evaluating the severity of alveolar proteinosis will be
established.
Description:
In past, investigators summarized a method that was the severity and prognosis of pulmonary
alveolar proteinosis (SPSP) to assess the severity and prognosis of patients with autoimmune
pulmonary alveolar proteinosis (auto PAP). The SPSP included five aspects: smoking, symptom,
PaO2, chest CT score at specific levels (aortic arch, carina, pulmonary vein confluence, and
superior septal level) and DLCO %predicted. But the chest CT score only focused on range of
lesions, and inaccurate. So, investigators plan to adopt new score which involves the
assessing to range and density.
In the new Chest HRCT score, we added the density score. The average density of the lesions
at a particular level of the patient's chest HRCT was measured by computer and classified
into three degrees: mild (less than -400), moderate (greater than -400 and less than -100)
and severe (greater than 100), denoted as 1 ', 2 'and3', respectively.
The range score of lung opacity was estimated using a five-point scale: no opacity = 0;
opacity involving < 25% of a region of hemithorax = 1; 25-50% = 2; 50-75% = 3; and ≥ 75% = 4.
The lesion score for each layer is equal to the density score multiplied by the range score.
The chest HRCT score was calculated by summing the lung opacity scores of the four
representative regions of each hemithorax, and divided into several level: no opacity = 0;
≤10 = 1; 11 - 20 = 2; 21 - 30 = 3; 31 -40 = 4; > 40 = 5.
According to the new chest HRCT score, the SPSP will be updated to SPSP II. In this study,
patients with auto PAP from three centers (Shanghai Lung Hospital, Peking Union Medical
College Hospital and Nanjing Drum Tower Hospital) were enrolled to evaluate the severity of
disease severity score (DSS), SPSP and SPSP II, respectively, to evaluate the pros and cons
of different scores and their impact on prognosis.
About 30 newly diagnosed auto PAP patients were recruited, and were assess disease severity
on the basis on SPSP II scores. According to SPSP II scores, appropriate treatment was used
for the patients, who were followed up for 3 months.
