Serum Dickkopf-4 as a Biomarker for the Diagnosis and Tre... | NCT02931981

Studies
Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor

NCT02931981

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Oct 13, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Gastrointestinal Stromal Tumor

Interventions

surgery or biopsy

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 2016

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

Oct 2016

Primary Completion Date

Oct 2016Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Oct 11, 2016

First Submission Date that Met QC Criteria

Oct 11, 2016

First Posted Date

Oct 13, 2016Estimated

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 11, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Our study aims to evaluate the role of Dickkopf-4 as biomarkers in the treatment of gastrointestinal stromal tumor.

Detailed Description

To identify whether Dickkopf-4 (DKK4) could be a potential biomarker for diagnosis and prognosis in patients with gastrointestinal stromal tumor (GIST). Serum was collected from 50 patients with GIST. Serological levels of DKK4 were examined by enzyme-linked immunosorbent assay (ELISA). The sensitivity and specificity was compared with modified NIH risk criteria. A 3-year follow-up was monitored to evaluate the correlation between DKK4 serum levels and relapse-free or overall survival. The expression of DKK4 in GIST tumor tissues was also evaluated using immunohistochemistry staining.

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

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery or biopsy	Procedure	Do radical surgery or biopsy to obtain a pathological result

Measure	Description	Time Frame
Overall Survival		3 years

Measure	Description	Time Frame
Relapse-free Survival		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary gastrointestinal stromal tumor confirmed pathologically by surgery or biopsy
Age from 18 - 70 years
No serious organic and mental illness;

Exclusion Criteria:

Pregnancy
No pathologic result
Suffering other malignancies at the same time.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with gastrointestinal stromal tumor.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hui Cao, PhD	Contact	008602168383751		caohuishcn@hotmail.com
Lin Tu, MD	Contact	008618616547270		tl19870228@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University	Recruiting	Shanghai		200127	China

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

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D001706	Biopsy

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided