Study on Clinical Features, Treatment Mode and Survival o... | NCT05468970

Studies
Study on Clinical Features, Treatment Mode and Survival of Bone and Soft Tissue Tumors

NCT05468970

Sponsor

Henan Cancer Hospital

Status

Recruiting

Last Update Posted

Sep 1, 2023Actual

Enrollment

6,000Estimated

Phase

Not provided

Conditions

Bone and Soft Tissue Tumors
Clinical Features

Interventions

NO Intervention

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2022Actual

Primary Completion Date

Jul 31, 2032Estimated

Completion Date

Jul 31, 2032Estimated

First Submitted Date

Jul 19, 2022

First Submission Date that Met QC Criteria

Jul 19, 2022

First Posted Date

Jul 21, 2022Actual

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

Aug 31, 2023

Last Update Posted Date

Sep 1, 2023Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor. This study is a single-center, prospective, real-world observational study that plans to enroll all eligible patients. Basic information, treatment methods, and prognostic information of these patients were collected.

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

6,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
NO Intervention	Other	NO Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Pathologically confirmed events leading to death	Up to approximately 120months
6/5000 Progression-free survival	The time from the first use of the treatment to the observation of disease progression	Up to approximately 48months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All ages, male and female.

The pathological diagnosis of BSTS in our hospital was a subtype.

Has received at least one hospitalization in this hospital.

The target lesions could be evaluated according to the efficacy evaluation criteria of solid tumor (RECIST; Version 1.1) Measure diameter changes.

Exclusion Criteria:

No definite pathology.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with bone and soft tissue tumors receiving inpatient treatment in Henan Tumor Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang Jiaqiang, Dr.	Contact	13592413731		wjqwtj@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Bone and Soft Tissue ,Henan Cancer Hospital	Recruiting	Zhengzhou	Henan	450008	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012983	Soft Tissue Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided