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Clinical Trials/NCT04143048
NCT04143048
Unknown
Not Applicable

A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules

The First Affiliated Hospital with Nanjing Medical University1 site in 1 country300 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Stromal Tumor
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Enrollment
300
Locations
1
Primary Endpoint
Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
Last Updated
5 years ago

Overview

Brief Summary

Gastrointestinal Stromal Tumors (GIST) is the most common mesenchymal tumor of the gastrointestinal tract, and the incidence rate in China has increased year by year in recent years.Gastrointestinal stromal tumors are not sensitive to radiotherapy and traditional infusion chemotherapy. Currently, they are generally treated with surgery, but they are prone to recurrence and metastasis.For nodules with a particle size between 2 and 5 cm, there may be both benign and malignant, and there is still a lack of fast and accurate methods for distinguishing benign and malignant.Many benign nodules were removed (in the pathological examination of postoperative resected tissue). In addition, if it is found to be late, there is a possibility of invading surrounding tissues and metastasis, so that it is impossible to cure. Therefore, early diagnosis and early surgery and benign and malignant differentiation of small nodules are the key to the clinical diagnosis and treatment of gastrointestinal stromal tumors.At present, second-generation gene sequencing (NGS) and liquid biopsy are rarely reported in the field of GIST. A few domestic and foreign studies have found that it can detect rare mutation types, and may find secondary gene mutations early, which has potential applicability, but Overall, the clinical guidance of these NGS-based studies focuses on prognosis and drug resistance , as well as some studies based on low-throughput platforms. Therefore, early diagnosis and benign and malignant discrimination based on high-throughput sequencing and liquid biopsy have significant clinical significance for the diagnosis and treatment of gastrointestinal stromal tumors.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
May 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients who are scheduled for stromal tumor resection
  • Signed informed consent

Exclusion Criteria

  • the vital signs are not stable
  • unconscious
  • unwilling to cooperate

Outcomes

Primary Outcomes

Genetic mutations of patients with stromal tumor assessed by next-generation sequencing

Time Frame: 2019.8-2019.10

DNA extraction of tumer tissue samples ,Preliminary exploration of tumor related mutation spectrum in different patients by gene sequencing

Secondary Outcomes

  • Genetic mutations of patients with stromal tumor assessed by next-generation sequencing(2019.11-2020.5)

Study Sites (1)

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