Multicenter Registration Study on Allergic Bronchopulmona... | NCT06645210

Studies
Multicenter Registration Study on Allergic Bronchopulmonary Aspergillosis

NCT06645210

Sponsor

Peking University Third Hospital

Status

Not yet recruiting

Last Update Posted

Oct 16, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Allergic Bronchopulmonary Aspergillosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Oct 11, 2024

First Submission Date that Met QC Criteria

Oct 15, 2024

First Posted Date

Oct 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2024

Last Update Posted Date

Oct 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sun Yongchang, Prof, Peking University Third HospitalPrincipal Investigator

Lead Sponsor

Peking University Third HospitalOTHER

Collaborators

Name	Class
First Affiliated Hospital of Guangxi Medical University	OTHER
Guangzhou Institute of Respiratory Disease	OTHER
Tongji Hospital	OTHER
Nanfang Hospital, Southern Medical University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To understand the current diagnosis and treatment status of ABPA patients, observe their clinical characteristics, prognosis, and treatment outcomes, and identify the relevant factors for poor prognosis in patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical classification and treatment response criteria for ABPA	Acute ABPA Response Remission Treatment-dependent ABPA Advanced ABPA	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meeting the diagnosis of ABPA according to the ABPA diagnostic criteria specified by the ISHAM-ABPA working group in 2024

Exclusion Criteria:

ABPA patients who are not first diagnosed in the center

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who were diagnosed with ABPA

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001229	Aspergillosis, Allergic Bronchopulmonary

Ancestor Terms

ID	Term
D055732	Pulmonary Aspergillosis
D001228	Aspergillosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided