Clinical Study of Gastric Cancer, Colorectal Cancer and Bladder Cancer Based on Liquid Biopsy

Colorectal Cancer Clinical Trial

Official title:

Clinical Study of Gastric Cancer, Colorectal Cancer and Bladder Cancer Based on Liquid Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385316
• Other study ID #: 2019-SR-369
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: xiqiao zhou, doctor
• Phone: 13951826318
• Email: xiqiao_zhou[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gastric cancer and colorectal cancer are common gastrointestinal malignancies in the world.Early cancer generally has no obvious symptoms. Endoscopy is the "gold standard"for the diagnosis of gastric cancer and colorectal cancer.gastric cancer and colorectal cancer treatment mainly includes surgery and medication.Compared with traditional diagnosis and treatment methods, the application of gene detection technology, especially high-throughput sequencing technology (NGS) in tumor diagnosis and treatment, performs multi-dimensional and multi-target detection of cancer-related genes, which can quickly and accurately determine the target gene mutations Morphology and expression differences, so as to provide personalized guidance to patients in terms of medication, treatment or prognosis evaluation, which can save a lot of time and treatment costs, and improve the overall treatment effect and patient quality of life.

Cystoscopy and biopsy sampling pathological testing are the gold standard for bladder cancer diagnosis, and have been widely used in clinical diagnosis and prognosis judgment. However, cystoscopy is cumbersome, expensive, and often causes pain to the patients under test. At present, the main clinical non-invasive detection technique for bladder cancer is still the cytological examination of urinary tract bladder cells in urine, and its sensitivity and specificity are not good, especially for the diagnosis of early lower grade bladder cancer.For bladder cancer, tumor tissue (puncture biopsy or surgical resection) DNA, urine ctDNA, urinary tract exfoliated cell DNA and peripheral blood ctDNA can be used for genetic testing, but the consistency of the genetic testing results of these four types of samples has not been verified, especially There is no systematic evaluation of the guidance effect of non-invasive gene detection of free tumor DNA and urinary tract shed cell DNA in the diagnosis and treatment of bladder cancer.The corresponding relationship between the significant mutation genes contained in the DNA derived from bladder urinary tract cancer and the various types and stages of bladder cancer is not clear.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who are scheduled for gastric tumor, colorectal tumor or bladder tumor resection Signed informed consent

Exclusion Criteria:

• the vital signs are not stable unconscious unwilling to cooperate

Related Conditions & MeSH terms

• Bladder Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer
• Stomach Neoplasms
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• DNA extraction of samples and high-throughput sequencing of small panels
DNA extraction of gastric tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed. DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels,DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood ctDNA and tissue gDNA for the gene detection of gastric tumor.
• DNA extraction of samples and high-throughput sequencing of small panels
DNA extraction of colorectal tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed. DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels,DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood ctDNA and tissue gDNA for the gene detection of colorectal tumor.
• DNA extraction of samples and high-throughput sequencing of small panels
DNA extraction of bladder tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed. DNA extraction of tumer tissue samples ,urine sample,blood sample and high-throughput sequencing of small panels,DNA extraction and small panel sequencing were performed for the three types of samples of the patients respectively, and the DNA sequencing results of the three types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood ctDNA ,urine ctDNAand tissue gDNA for the gene detection of bladder tumor.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical Universit	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA extraction of tumer tissue samples and high-throughput sequencing	Preliminary exploration of tumor related mutation spectrum in different patients by gene sequencing	2019.9-2019.6
Secondary	DNA extraction of tumer tissue samples, blood tissue and urine samples and high-throughput sequencing	To evaluate the consistency of peripheral blood ctDNA and tissue gDNA in gene detection of gastric cancer and colorectal cancer.; To evaluate the consistency of peripheral blood ctDNA , urine ctDNA and tissue gDNA in gene detection of bladder cancer.	2020.7-2020.12