Study for the Clinical Roadmap and Prognosis of Pulmonary... | NCT06165718

Studies
Study for the Clinical Roadmap and Prognosis of Pulmonary Artery Sarcoma.

NCT06165718

Sponsor

China-Japan Friendship Hospital

Status

Unknown status

Last Update Posted

Dec 15, 2023Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Pulmonary Artery Sarcoma

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Dec 4, 2023

First Submission Date that Met QC Criteria

Dec 4, 2023

First Posted Date

Dec 11, 2023Actual

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

Dec 11, 2023

Last Update Posted Date

Dec 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wanmu Xie, Professor, China-Japan Friendship HospitalPrincipal Investigator

Lead Sponsor

China-Japan Friendship HospitalOTHER

Collaborators

Name	Class
The First Affiliated Hospital of Guangzhou Medical University	OTHER
Beijing Chao Yang Hospital	OTHER
Shanghai Pulmonary Hospital, Shanghai, China	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study in which patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

Detailed Description

This is an observational study covering mainland China, and patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

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

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival	Time to death or disease progression	36 months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Time to death	36 months
Postoperative survival	Time from surgery to death	36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Computed tomography pulmonary angiography indicated that there were intraluminal defects
Malignant histopathology was sarcoma
Informed consent form was signed

Exclusion Criteria:

Life expectancy was less than 3 months due to diseases other than pulmonary artery sarcoma
Expected inability to complete follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pulmonary artery sarcoma patients expected to complete follow-up

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wanmu Xie	Contact	+86 15611734410		xiewanmu@126.com

Overall Officials

Name	Affiliation	Role
Wanmu Xie	China-Japan Friendship Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China-Japan Friendship Hospital	Recruiting	Beijing	Beijing Municipality	100029	China