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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02931981
Other study ID # GIST-DKK4
Secondary ID
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


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
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