- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02931981
Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor
October 11, 2016 updated by: RenJi Hospital
Our study aims to evaluate the role of Dickkopf-4 as biomarkers in the treatment of gastrointestinal stromal tumor.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Tu, MD
- Phone Number: 008618616547270
- Email: tl19870228@hotmail.com
Study Contact Backup
- Name: Hui Cao, PhD
- Phone Number: 008602168383751
- Email: caohuishcn@hotmail.com
Study Locations
-
-
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Shanghai, China, 200127
- Recruiting
- Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
-
Contact:
- Qi Lu
- Phone Number: 0086-021-68383364
- Email: rjluqi@hotmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with gastrointestinal stromal tumor.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse-free Survival
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
October 11, 2016
First Posted (Estimate)
October 13, 2016
Study Record Updates
Last Update Posted (Estimate)
October 13, 2016
Last Update Submitted That Met QC Criteria
October 11, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIST-DKK4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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