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

Gastrointestinal Stromal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02931981
• Other study ID #: GIST-DKK4
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 11, 2016
• Start date: October 2016
• Est. completion date: October 2019

Study information

• Verified date: October 2016
• Source: RenJi Hospital
• Contact: Hui Cao, PhD
• Phone: 008602168383751
• Email: caohuishcn[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2019
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

Intervention

Procedure:
• surgery or biopsy
Do radical surgery or biopsy to obtain a pathological result

Locations

Country	Name	City	State
China	Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		3 years	Yes
Secondary	Relapse-free Survival		3 years	Yes