NCT04143048

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

Status unknown Last updated 11 May 2020

What this trial tests

trial testing DNA extraction of tumer tissue samples and high-throughput sequencing of small panels in Gastrointestinal Stromal Tumor in 300 participants. Status unknown.

Timeline

1 September 2019

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 September 2019
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	1 location across China

Drugs / interventions tested

• DNA extraction of tumer tissue samples and high-throughput sequencing of small panels
• DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
• DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels

Conditions studied

• Gastrointestinal Stromal Tumor — all drugs for Gastrointestinal Stromal Tumor →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Eligibility, any sex, with Gastrointestinal Stromal Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.