Gastric CancerNCT04385316
Clinical Study of Gastric Cancer, Colorectal Cancer and Bladder Cancer Based on Liquid Biopsy
An observational study of Gastric Cancer and Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer, Bladder Cancer
- What is being tested?
- DNA extraction of samples and high-throughput sequencing of small panels
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Gastric cancer, colorectal cancer or bladder cancer patients in Jiangsu Provincial People's Hospital
Who may be able to join
- Patients who are scheduled for gastric tumor, colorectal tumor or bladder tumor resection Signed informed consent
Who cannot join
- the vital signs are not stable unconscious unwilling to cooperate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical Universit
Nanjing, Jiangsu, 210029
Xiqiao none Zhou, doctor, 13951826318, Xiqiao_zhou@126.com
About this study
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.
- Conditions
- Gastric Cancer, Colorectal Cancer, Bladder Cancer
- Being tested
- DNA extraction of samples and high-throughput sequencing of small panels
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA extraction of samples and high-throughput sequencing of small panelsDiagnostic test
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 panelsDiagnostic test
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 panelsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Cancer | Not described Receives: Diagnostic Test: DNA extraction of samples and high-throughput sequencing of small panels | |
| Colorectal Cancer | Not described Receives: Diagnostic Test: DNA extraction of samples and high-throughput sequencing of small panels | |
| Bladder Cancer | Not described Receives: Diagnostic Test: DNA extraction of samples and high-throughput sequencing of small panels |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA extraction of tumer tissue samples and high-throughput sequencing
Preliminary exploration of tumor related mutation spectrum in different patients by gene sequencing
Measured: 2019.9-2019.6
Secondary outcomes (1)
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.
Measured: 2020.7-2020.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Sep 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385316
- Sponsor's protocol ID
- 2019-SR-369
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Gastric Cancer, Colorectal Cancer and Bladder Cancer Based on Liquid Biopsy
- ClinicalTrials.gov ID
- NCT04385316
- Acronym / sponsor ID
- 2019-SR-369
- Conditions
- Gastric Cancer, Colorectal Cancer, Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric Cancer | – | Diagnostic Test: DNA extraction of samples and high-throughput sequencing of small panels |
| Colorectal Cancer | – | Diagnostic Test: DNA extraction of samples and high-throughput sequencing of small panels |
| Bladder Cancer | – | Diagnostic Test: DNA extraction of samples and high-throughput sequencing of small panels |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Gastric cancer, colorectal cancer or bladder cancer patients in Jiangsu Provincial People's Hospital
Key inclusion criteria (1 listed)
- Patients who are scheduled for gastric tumor, colorectal tumor or bladder tumor resection Signed informed consent
Key exclusion criteria (1 listed)
- the vital signs are not stable unconscious unwilling to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA extraction of samples and high-throughput sequencing of small panelsDNA 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. | Diagnostic test | Gastric Cancer |
| DNA extraction of samples and high-throughput sequencing of small panelsDNA 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. | Diagnostic test | Colorectal Cancer |
| DNA extraction of samples and high-throughput sequencing of small panelsDNA 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. | Diagnostic test | Bladder Cancer |
Primary outcome
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
1 secondary outcome
DNA extraction of tumer tissue samples, blood tissue and urine samples and high-throughput sequencing
Time frame: 2020.7-2020.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiqiao zhou, doctor (13951826318, xiqiao_zhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA extraction of tumer tissue samples and high-throughput sequencing (time frame: 2019.9-2019.6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.