PathologyNCT03376815
Tumor Landscape Pathological Diagnosis by Large Tissue Sections
An observational study of Pathology, run by Shanghai Zhongshan Hospital.
Trial summary
The aim of this study is to establish large tissue sections for 10 kinds of tumors. in order to observe the tumor landscape on microscope. The tumors including esophageal carcinoma,gastric carcinoma,hepatocellular carcinoma etc.200 cases of each tumor will be compared by traditional sample method and landscape sample… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pathology
- What is being tested?
- landscape sample method
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 30 Jun 2021
- How long will I take part?
- 3 Years
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: ZhongShan Hospital，FuDan University
Who may be able to join
- Older than 15-year-old
- Did not receive preoperative preoperative chemotherapy or radiotherapy
Who cannot join
- patients undergoing preoperative chemotherapy or radiotherapy
About this study
The aim of this study is to establish large tissue sections for 10 kinds of tumors. in order to observe the tumor landscape on microscope. The tumors including esophageal carcinoma,gastric carcinoma,hepatocellular carcinoma etc.200 cases of each tumor will be compared by traditional sample method and landscape sample method to testify the clinical value and significance of tumor landscape pathological diagnosis .
- Conditions
- Pathology
- Being tested
- landscape sample method
- Keywords
- Tumor ,landscape ,pathological diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
landscape sample methodDiagnostic test
Also called traditional sample method
200 cases of different tumor tissues will be compared by traditional sample method and landscape sample method to testify the clinical value and significance of tumor landscape pathological diagnosis .
| Study group | Role | What they receive |
|---|---|---|
| prostate ,traditional sample method | Samples from 100 patients with prostate carcinoma were obtained by traditional sampling method | |
| prostate ,landscape sample method | Samples from 100 patients with prostate carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| liver, traditional sample method | Samples from 100 patients with liver cancer were obtained by traditional sampling method. | |
| liver,landscape sample method | Samples from 100 patients with liver cancer were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| esophageal ,traditional sample method | Samples from 100 patients with esophageal carcinoma were obtained by traditional sampling method. | |
| esophageal ,landscape sample method | Samples from 100 patients with esophageal carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| GIST,traditional sample method | Samples from 100 patients with gastrointestinal stromal tumor were obtained by traditional sampling method. | |
| GIST,landscape sample method | Samples from 100 patients with gastrointestinal stromal tumor were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| colorectal ,traditional sample method | Samples from 100 patients with colorectal carcinoma were obtained by traditional sampling method. | |
| colorectal ,landscape sample method | Samples from 100 patients with colorectal carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| pancreatic ,traditional sample method | Samples from 100 patients with pancreatic carcinoma were obtained by traditional sampling method. | |
| pancreatic,landscape sample method | Samples from 100 patients with pancreatic carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| lung cancer,traditional sample method | Samples from 100 patients with lung cancer were obtained by traditional sampling method. | |
| lung cancer,landscape sample method | Samples from 100 patients with lung cancer were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| Renal ,traditional sample method | Samples from 100 patients with renal carcinoma were obtained by traditional sampling method. | |
| Renal carcinoma,landscape sample method | Samples from 100 patients with renal carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| Breast cancer,traditional sample method | Samples from 100 patients with breast cancer were obtained by traditional sampling method. | |
| Breast cancer,landscape sample method | Samples from 100 patients with breast cancer were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method | |
| cervical ,traditional sample method | Samples from 100 patients with cervical carcinoma were obtained by traditional sampling method. | |
| cervical ,landscape sample method | Samples from 100 patients with cervical carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . Receives: Diagnostic Test: landscape sample method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate，traditional and landscape sample method
200 cases of prostate carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st January, 2018 ~30th June, 2018
liver,traditional and landscape sample method
200 cases of liver cancer sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st January, 2018 ~30th June, 2018
esophageal,traditional and landscape sample method
200 cases of esophageal carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st January, 2018 ~30th June, 2018
GIST,traditional and landscape sample method
200 cases of gastrointestinal stromal tumor (GIST)sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st July, 2018 ~31st December, 2018
colorectal,traditional and landscape sample method
200 cases of colorectal carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st July, 2018 ~31st December, 2018
pancreatic,traditional and landscape sample method
200 cases of pancreatic carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st July, 2018 ~31st December, 2018
lung, traditional and landscape sample method
200 cases of lung cancer sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st July, 2018 ~31st December, 2018
renal,traditional and landscape sample method
200 cases of renal carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st July, 2018 ~31st December, 2018
breast,traditional and landscape sample method
200 cases of breast cancer sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st July, 2018 ~31st December, 2018
cervical,traditional and landscape sample method
200 cases of cervical carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Measured: 1st July, 2018 ~31st December, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PathologyStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376815
- Sponsor's protocol ID
- B2017-113R
- Status last verified
- Dec 2017
- First submitted
- 9 Nov 2017
- Last updated
- 19 Dec 2017
- 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 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Landscape Pathological Diagnosis by Large Tissue Sections
- ClinicalTrials.gov ID
- NCT03376815
- Acronym / sponsor ID
- B2017-113R
- Conditions
- Pathology
- Keywords
- Tumor ,landscape ,pathological diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 19 Dec 2017 (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.
The aim of this study is to establish large tissue sections for 10 kinds of tumors. in order to observe the tumor landscape on microscope. The tumors including esophageal carcinoma,gastric carcinoma,hepatocellular carcinoma etc.200 cases of each tumor will be compared by traditional sample method and landscape sample method to testify the clinical value and significance of tumor landscape pathological diagnosis .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| prostate ,traditional sample method | – | –Samples from 100 patients with prostate carcinoma were obtained by traditional sampling method |
| prostate ,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with prostate carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| liver, traditional sample method | – | –Samples from 100 patients with liver cancer were obtained by traditional sampling method. |
| liver,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with liver cancer were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| esophageal ,traditional sample method | – | –Samples from 100 patients with esophageal carcinoma were obtained by traditional sampling method. |
| esophageal ,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with esophageal carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| GIST,traditional sample method | – | –Samples from 100 patients with gastrointestinal stromal tumor were obtained by traditional sampling method. |
| GIST,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with gastrointestinal stromal tumor were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| colorectal ,traditional sample method | – | –Samples from 100 patients with colorectal carcinoma were obtained by traditional sampling method. |
| colorectal ,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with colorectal carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| pancreatic ,traditional sample method | – | –Samples from 100 patients with pancreatic carcinoma were obtained by traditional sampling method. |
| pancreatic,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with pancreatic carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| lung cancer,traditional sample method | – | –Samples from 100 patients with lung cancer were obtained by traditional sampling method. |
| lung cancer,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with lung cancer were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| Renal ,traditional sample method | – | –Samples from 100 patients with renal carcinoma were obtained by traditional sampling method. |
| Renal carcinoma,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with renal carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| Breast cancer,traditional sample method | – | –Samples from 100 patients with breast cancer were obtained by traditional sampling method. |
| Breast cancer,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with breast cancer were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
| cervical ,traditional sample method | – | –Samples from 100 patients with cervical carcinoma were obtained by traditional sampling method. |
| cervical ,landscape sample method | – | Diagnostic Test: landscape sample methodSamples from 100 patients with cervical carcinoma were obtained by landscape sampling method to testify the clinical value and significance of tumor landscape pathological diagnosis . |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ZhongShan Hospital，FuDan University
Key inclusion criteria (2 listed)
- Older than 15-year-old
- Did not receive preoperative preoperative chemotherapy or radiotherapy
Key exclusion criteria (1 listed)
- patients undergoing preoperative chemotherapy or radiotherapy
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 |
|---|---|---|
| landscape sample methodAlso: traditional sample method200 cases of different tumor tissues will be compared by traditional sample method and landscape sample method to testify the clinical value and significance of tumor landscape pathological diagnosis . | Diagnostic test | Breast cancer,landscape sample method, GIST,landscape sample method, Renal carcinoma,landscape sample method, cervical ,landscape sample method, colorectal ,landscape sample method, esophageal ,landscape sample method, liver,landscape sample method, lung cancer,landscape sample method, pancreatic,landscape sample method, prostate ,landscape sample method |
Primary outcome
Prostate，traditional and landscape sample method
Time frame: 1st January, 2018 ~30th June, 2018
200 cases of prostate carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
liver,traditional and landscape sample method
Time frame: 1st January, 2018 ~30th June, 2018
200 cases of liver cancer sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
esophageal,traditional and landscape sample method
Time frame: 1st January, 2018 ~30th June, 2018
200 cases of esophageal carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
GIST,traditional and landscape sample method
Time frame: 1st July, 2018 ~31st December, 2018
200 cases of gastrointestinal stromal tumor (GIST)sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
colorectal,traditional and landscape sample method
Time frame: 1st July, 2018 ~31st December, 2018
200 cases of colorectal carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
pancreatic,traditional and landscape sample method
Time frame: 1st July, 2018 ~31st December, 2018
200 cases of pancreatic carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
lung, traditional and landscape sample method
Time frame: 1st July, 2018 ~31st December, 2018
200 cases of lung cancer sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
renal,traditional and landscape sample method
Time frame: 1st July, 2018 ~31st December, 2018
200 cases of renal carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
breast,traditional and landscape sample method
Time frame: 1st July, 2018 ~31st December, 2018
200 cases of breast cancer sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
cervical,traditional and landscape sample method
Time frame: 1st July, 2018 ~31st December, 2018
200 cases of cervical carcinoma sampled by traditional method and landscape method will be compared for precise and comprehensive pathological analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathology, run by Shanghai Zhongshan Hospital.
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 2 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate，traditional and landscape sample method (time frame: 1st January, 2018 ~30th June, 2018). The study lists 10 primary outcomes in all. 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 19 Dec 2017.