Clinical Study of Gastric Cancer, Colorectal Cancer and Bladder Cancer Based on Liquid Biopsy
1 other identifier
observational
3
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 8, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 12, 2020
May 1, 2020
1.3 years
May 8, 2020
May 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
DNA extraction of tumer tissue samples, blood tissue and urine samples and high-throughput sequencing
2020.7-2020.12
Study Arms (3)
Gastric Cancer
Colorectal Cancer
Bladder Cancer
Interventions
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.
Eligibility Criteria
Gastric cancer, colorectal cancer or bladder cancer patients in Jiangsu Provincial People's Hospital
You may qualify if:
- Patients who are scheduled for gastric tumor, colorectal tumor or bladder tumor resection Signed informed consent
You may not qualify if:
- the vital signs are not stable unconscious unwilling to cooperate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Nanjing Medical Universit
Nanjing, Jiangsu, 210029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2020
First Posted
May 12, 2020
Study Start
September 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
May 12, 2020
Record last verified: 2020-05