Esophagus CancerNCT03237130
Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics
An observational study of Esophagus Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- preoperative enhanced chest CT examination
- Type of treatment
- Surgery or procedure
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2017to 15 May 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: pathologically proven esophageal cancer patients who receive preoperative CT and surgical resection in our hospital.
Who may be able to join
- pathologically proven esophageal cancer
- scheduled to preoperative enhanced chest CT and undergo surgery
- sign the patient informed consent
Who cannot join
- failed to receive preoperative enhanced chest CT or undergo surgery
- inavailable pathological results for local lymph node status
- inquality of CT images for feature extraction
- patient quit
Trial locations and contacts
1 site in 1 country.
About this study
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer.
Read the detailed description
This study proposes to establish an image feature extraction and selection method for identifying lymph node metastasis of esophageal cancer.The study will consider the relationship between the main lesion and the suspected lymph node, extract association characteristics in order to improve the sensitivity and specificity of the CT radiomics-based prediction model for identifying metastasis lymph nodes. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.
- Conditions
- Esophagus Cancer
- Being tested
- preoperative enhanced chest CT examination
- Keywords
- esophagus cancer; radiomics; computed tomograpy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative enhanced chest CT examinationProcedure or surgery
Each patient will receive preoperative enhanced chest CT examination, and their CT images will be used for analysis
| Study group | Role | What they receive |
|---|---|---|
| preoperative enhanced chest CT | The cohort contains patients with preoperative therapies and patients without preoperative therapies. Each patient receives regular preoperative enhanced chest CT; for patients with preoperative therapies, they usually undergo twice enhanced chest CT examination at before and after preoperative therapies, the CT images after preoperative therapies will be used for analysis Receives: Procedure: preoperative enhanced chest CT examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological local lymph node status
pathological lymph node status is defined as lymph node metastasis exist or not
Measured: Pathologic evaluation will be performed for each patient within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start15 Feb 2017
- Primary completion7 Nov 2019
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Ying-Shi, Peking University Cancer Hospital & Institute
- Investigators
- Ying-Shi Sun, MD, Study chair, Dept.Radiology,Peking University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237130
- Sponsor's protocol ID
- CTRadiomics-LMesophagus-BNSF
- Status last verified
- Jan 2021
- First submitted
- 31 Jul 2017
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics
- ClinicalTrials.gov ID
- NCT03237130
- Acronym / sponsor ID
- CTRadiomics-LMesophagus-BNSF
- Conditions
- Esophagus Cancer
- Keywords
- esophagus cancer; radiomics; computed tomograpy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 2 Aug 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.
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer.
Detailed description
This study proposes to establish an image feature extraction and selection method for identifying lymph node metastasis of esophageal cancer.The study will consider the relationship between the main lesion and the suspected lymph node, extract association characteristics in order to improve the sensitivity and specificity of the CT radiomics-based prediction model for identifying metastasis lymph nodes. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative enhanced chest CT | – | Procedure: preoperative enhanced chest CT examinationThe cohort contains patients with preoperative therapies and patients without preoperative therapies. Each patient receives regular preoperative enhanced chest CT; for patients with preoperative therapies, they usually undergo twice enhanced chest CT examination at before and after preoperative therapies, the CT images after preoperative therapies will be used for analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pathologically proven esophageal cancer patients who receive preoperative CT and surgical resection in our hospital.
Key inclusion criteria (3 listed)
- pathologically proven esophageal cancer
- scheduled to preoperative enhanced chest CT and undergo surgery
- sign the patient informed consent
Key exclusion criteria (4 listed)
- failed to receive preoperative enhanced chest CT or undergo surgery
- inavailable pathological results for local lymph node status
- inquality of CT images for feature extraction
- patient quit
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 |
|---|---|---|
| preoperative enhanced chest CT examinationEach patient will receive preoperative enhanced chest CT examination, and their CT images will be used for analysis | Procedure or surgery | preoperative enhanced chest CT |
Primary outcome
pathological local lymph node status
Time frame: Pathologic evaluation will be performed for each patient within 1 week after surgery
pathological lymph node status is defined as lymph node metastasis exist or not
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ying-Shi Sun, MD study chair
Dept.Radiology,Peking University Cancer Hospital
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 Esophagus Cancer, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pathological local lymph node status (time frame: Pathologic evaluation will be performed for each patient within 1 week after surgery). 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 2 Feb 2021.