Gastrointestinal NeoplasmsNCT02226224
Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro
An observational study of Gastrointestinal Neoplasms, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
In our era of personalized treatment, both the prognosis and the choice of therapy for upper GI malignancies depend on the staging before any treatment. Most experts recommend EUS (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in clinical practice varies in different centers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced upper GI carcinoma receive surgery as first treatment no previous surgery involved the upper GI tract
Who may be able to join
- Patients with upper GI carcinoma
- Receive surgery as first treatment
Who cannot join
- previous surgery involved the upper GI tract
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yan Yan, Doctor, 861088196168, dr.yan@outlook.com
Yan Yan, Doctor
About this study
In our era of personalized treatment, both the prognosis and the choice of therapy for upper GI malignancies depend on the staging before any treatment. Most experts recommend EUS (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in clinical practice varies in different centers according to the published data. Neither the discrepancy between EUS and histological findings nor the variation between centers well explained. So the investigators designed this prospective study. In the present study, the investigators performed EUS on the resected specimen after surgery before fixation in formalin, evaluated the invasion of the GI wall, and marked the deepest location with sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy between EUS and histologic findings.
Read the detailed description
- EUS Examination After the surgery, the specimen is filled with 0.9%NS (normal saline ) without cut open，and put into a container filled with 0.9%NS before fixation in formalin. EUS will be performed on the resected specimen.The endoscopy move from the distal to proximal side along the longitudinal axis of stomach, evaluate the invasion of gastric wall, and mark the deepest point with sutures under the EUS guided. The images were stored .
EUS images the are reviewed by two endoscopists. They are asked to stage the tumor according to the AJCC(American Joint Committee on Cancer) staging system (7th edition) , assign a level of confidence to the staging, and score the quality of the EUS image .
- Histologic Preparations and Examination Carcinoma invasion into each layer of the gastric wall is diagnosed by an experienced pathologist (L.ZW) who is unaware of the findings of the EUS imaging. The marked section will be assessed separately.
- Data analysis The diagnosis between the pathologic findings and EUS prediction will be compared. Whether the marked point was the deepest in pathologic findings is recorded. And the histological section and the EUS image of the marked point is compared.
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- gastrointestinal neoplasms, endosonography, in vitro, Staging
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| early gastric cancer | EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen | |
| Locally Advanced Gastric Cancer | EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen | |
| early esophagus cancer | EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen | |
| locally advanced esophagus cancer | EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
the consistency between EUS and pathologic determination of tumor depth
Measured: 1 month （after careful examination by 2 pathologists）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Yan, Peking University Cancer Hospital & Institute
- Investigators
- Yan Yan, Doctor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226224
- Sponsor's protocol ID
- EC1001
- Status last verified
- Jul 2017
- First submitted
- 24 Aug 2014
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro
- ClinicalTrials.gov ID
- NCT02226224
- Acronym / sponsor ID
- EC1001
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- gastrointestinal neoplasms, endosonography, in vitro, Staging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 27 Aug 2014 (estimated)
- 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.
In our era of personalized treatment, both the prognosis and the choice of therapy for upper GI malignancies depend on the staging before any treatment. Most experts recommend EUS (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in clinical practice varies in different centers according to the published data. Neither the discrepancy between EUS and histological findings nor the variation between centers well explained. So the investigators designed this prospective study. In the present study, the investigators performed EUS on the resected specimen after surgery before fixation in formalin, evaluated the invasion of the GI wall, and marked the deepest location with sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy between EUS and histologic findings.
Detailed description
- EUS Examination After the surgery, the specimen is filled with 0.9%NS (normal saline ) without cut open，and put into a container filled with 0.9%NS before fixation in formalin. EUS will be performed on the resected specimen.The endoscopy move from the distal to proximal side along the longitudinal axis of stomach, evaluate the invasion of gastric wall, and mark the deepest point with sutures under the EUS guided. The images were stored .
EUS images the are reviewed by two endoscopists. They are asked to stage the tumor according to the AJCC(American Joint Committee on Cancer) staging system (7th edition) , assign a level of confidence to the staging, and score the quality of the EUS image .
- Histologic Preparations and Examination Carcinoma invasion into each layer of the gastric wall is diagnosed by an experienced pathologist (L.ZW) who is unaware of the findings of the EUS imaging. The marked section will be assessed separately.
- Data analysis The diagnosis between the pathologic findings and EUS prediction will be compared. Whether the marked point was the deepest in pathologic findings is recorded. And the histological section and the EUS image of the marked point is compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| early gastric cancer | – | –EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen |
| Locally Advanced Gastric Cancer | – | –EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen |
| early esophagus cancer | – | –EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen |
| locally advanced esophagus cancer | – | –EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced upper GI carcinoma receive surgery as first treatment no previous surgery involved the upper GI tract
Key inclusion criteria (2 listed)
- Patients with upper GI carcinoma
- Receive surgery as first treatment
Key exclusion criteria (1 listed)
- previous surgery involved the upper GI tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the consistency between EUS and pathologic determination of tumor depth
Time frame: 1 month （after careful examination by 2 pathologists）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
Yan Yan, Doctor principal investigator
Peking University Cancer Hospital & Institute
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 Gastrointestinal Neoplasms, run by Peking University Cancer Hospital & Institute 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 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 18 Jul 2017. 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 Yan Yan, Doctor (861088196168, dr.yan@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the consistency between EUS and pathologic determination of tumor depth (time frame: 1 month （after careful examination by 2 pathologists）). 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 18 Jul 2017.