Clinical Outcome of Female Non-gastric Gastrointestinal S... | NCT04256226

Studies
Clinical Outcome of Female Non-gastric Gastrointestinal Stromal Tumor

NCT04256226

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Jun 2, 2020Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Gastrointestinal Stromal Tumor

Interventions

Tumor excision

Countries

Taiwan

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Feb 4, 2020

First Submission Date that Met QC Criteria

Feb 4, 2020

First Posted Date

Feb 5, 2020Actual

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

May 31, 2020

Last Update Posted Date

Jun 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

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

To elucidate the prognosis of women with non-gastric primary gastrointestinal stromal tumors.

Detailed Description

Gastrointestinal stromal tumor (GIST) are mesenchymal tumors arising from gastrointestinal tract, mesentery, or omentum. They took up about 3% of gastrointestinal malignancies. Although rarely, the clinical presentation of non-gastric GIST might mimick ovarian cancer, and would be managed by gynecologists. Therefore, retrospective review of female non-gastric GIST cases will be performed to investigate the clinical outcome of non-gastric GIST. The result of this study might be used as an important reference for gynecologists.

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

26Actual

Name	Type	Description	Arm Group Labels	Other Names
Tumor excision	Procedure	Excision of GIST

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	The date of surgery to the date of death or last follow-up	20 years

Secondary Outcomes

Measure	Description	Time Frame
Recurrence-free survival	The date of surgery to the date of recurrence or last follow-up	20 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 20 years of women.
non-gastric gastrointestinal stromal tumor

Exclusion Criteria:

Those without pathological report or surgical record.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

non-gastric gastrointestinal tumor in women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital		Banqiao District	New Taipei	22050	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D046152	Gastrointestinal Stromal Tumors

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided