- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04385316
Clinical Study of Gastric Cancer, Colorectal Cancer and Bladder Cancer Based on Liquid Biopsy
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: xiqiao zhou, doctor
- Phone Number: 13951826318
- Email: xiqiao_zhou@126.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- First Affiliated Hospital of Nanjing Medical Universit
-
Contact:
- Xiqiao none Zhou, doctor
- Phone Number: 13951826318
- Email: Xiqiao_zhou@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gastric Cancer
|
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 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 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. |
Colorectal Cancer
|
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 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 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. |
Bladder Cancer
|
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 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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DNA extraction of tumer tissue samples and high-throughput sequencing
Time Frame: 2019.9-2019.6
|
Preliminary exploration of tumor related mutation spectrum in different patients by gene sequencing
|
2019.9-2019.6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DNA extraction of tumer tissue samples, blood tissue and urine samples and high-throughput sequencing
Time Frame: 2020.7-2020.12
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Stomach Neoplasms
- Colorectal Neoplasms
- Urinary Bladder Neoplasms
Other Study ID Numbers
- 2019-SR-369
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Gastric Cancer
-
City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditionsUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7United States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedGastric Cancer | Gastric NeoplasmsUnited States
-
AIO-Studien-gGmbHBristol-Myers SquibbCompletedGastric Cancer | Esophageal Cancer | Adenocarcinoma Gastric | Metastatic Gastric Cancer | GastroEsophageal Cancer | HER2 Positive Gastric CancerGermany
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)RecruitingGastric Adenocarcinoma | Epstein-Barr Virus Positive | Mismatch Repair Protein Deficiency | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage III Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage... and other conditionsUnited States
Clinical Trials on DNA extraction of samples and high-throughput sequencing of small panels
-
The First Affiliated Hospital with Nanjing Medical...Fudan UniversityUnknownGastrointestinal Stromal TumorChina
-
Université Libre de BruxellesDESCARTES Working Group On TransplantationCompleted
-
Barzilai Medical CenterUnknownOral Squamous Cell Carcinoma | Medication Related Osteonecrosis of the Jaw | Oral Epithelial DysplasiaIsrael
-
Assistance Publique - Hôpitaux de ParisSociété ADEMTECH SACompletedInvasive Aspergillosis in Patients With Onco-haematological DiseasesFrance
-
Australian & New Zealand Children's Haematology...Medical Research Future Fund; Minderoo Foundation; Children's Cancer Institute...RecruitingChildhood Cancer | Relapsed Cancer | Refractory Cancer | Childhood Leukemia | Childhood Solid Tumor | Childhood Brain TumorAustralia
-
Rennes University HospitalCompleted
-
Istituto Ortopedico GaleazziUnknownArthritis, Rheumatoid | Bone ErosionItaly
-
Karolinska InstitutetRecruiting
-
Imperial College LondonRoyal Free Hospital NHS Foundation Trust; Royal Surrey County Hospital NHS...CompletedPancreatic Cancer | Cholangiocarcinoma | Biliary Stricture | Gallstone Disease | Ampullary CancerUnited Kingdom
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; Centre National...Unknown