Early Esophageal CancerNCT06515964
China Early Esophageal Cancer Cohort
An observational study of Early Esophageal Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
With the development of endoscopy, more and more patients with superficial esophageal squamous cell carcinoma (ESCC) receive endoscopic resection rather than traditional surgery. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Early Esophageal Cancer
- What is being tested?
- observational study
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Oct 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From January 2015 to December 2020, no less than 1400 patients who received ESD treatment for early esophageal squamous cell carcinoma were expected to be included.
Who may be able to join
- Men and women, aged 18-85.
- ESD was performed for early (superficial) esophageal squamous cell carcinoma, and the indication was in line with domestic and foreign guidelines.
- The pathological stage after ESD was pT1a/pT1b.
- The effective follow-up time after ESD was ≥3 years, or recurrence or LNM occurred during the follow-up period.
Who cannot join
- Esophageal chemoradiotherapy or esophageal surgery were performed before ESD.
- There is a history of carcinoma, early carcinoma, adenoma and other benign and malignant tumors of stomach and duodenum.
- Pathological data after ESD were incomplete.
- Combined with malignant tumors of other organs.
- Fragmented endoscopic mucosal resection (EMR), multi-loop mucosal resection (MBM) and other endoscopic non-monolithic resection techniques were used.
- New squamous cell carcinoma in other parts of esophagus during follow-up (metachronous carcinoma).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Lei Xin, MD, 13817318134, aip_xin@163.com
Luowei Wang, MD
About this study
Official title: Development and Validation of a Curability Evaluation Model for Endoscopic Resection of Early Esophageal Squamous Cell Carcinoma Based on China Early Esophageal Cancer Cohort
With the development of endoscopy, more and more patients with superficial esophageal squamous cell carcinoma (ESCC) receive endoscopic resection rather than traditional surgery. However, there is still no complete consensus on the risk factors for lymph node metastasis (LNM) and recurrence of ESCC after endoscopic resection. The existing curative resection criteria are strict to a certain extent, and a considerable number of patients are overtreated according to the current standard of additional treatment. Thus, we aim to conduct a multi-center retrospective and prospective study to construct a large cohort of ESCC based on the previously established multi-center collaborative research network and clinical big data, analyze the risk factors of LNM and recurrence in patients with early esophageal squamous cell carcinoma after ESD, establish an accurate and simple risk prediction model, and evaluate the discrimination efficiency of this model.
- Conditions
- Early Esophageal Cancer
- Being tested
- observational study
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study, no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Noncurative Resection
Noncurative resection was defined as the presence of residual tumor or lymph node metastasis at the vertical margin of the lesion confirmed by pathology after surgery, or local recurrence, lymph node metastasis, or distant metastasis attributable to the primary tumor during follow-up.
Measured: 2022-12 Complete the preliminary clinical study preparation. 2023-10 Complete patient data analysis and sorting. 2024-10 Construct an accurate evaluation system. 2025-10 Conduct validation analysis of the evaluation system.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lianshui People's Hospital, The second affiliated hospital of Xuzhou medical university, Nanning Second People's Hospital, Nanchong Central Hospital, Tongliao City Hospital, Yancheng First People's Hospital, The Second Hospital of Hebei Medical University, The Second Affiliated Hospital of Baotou Medical College, Affiliated Hospital of Southwest Medical University, Sichuan Cancer Hospital and Research Institute, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Zhongda Hospital, The First Affiliated Hospital with Nanjing Medical University, West China Hospital, The First Affiliated Hospital of Soochow University, Jiangsu Province Hospital of Traditional Chinese Medicine, Shandong Provincial Hospital, Shanxi Provincial People's Hospital, Henan Provincial People's Hospital, Anyang Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515964
- Sponsor's protocol ID
- CEEC
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Curability Evaluation Model for Endoscopic Resection of Early Esophageal Squamous Cell Carcinoma Based on China Early Esophageal Cancer Cohort
- ClinicalTrials.gov ID
- NCT06515964
- Acronym / sponsor ID
- CEEC
- Conditions
- Early Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Lianshui People's Hospital, The second affiliated hospital of Xuzhou medical university, Nanning Second People's Hospital, Nanchong Central Hospital, Tongliao City Hospital, Yancheng First People's Hospital, The Second Hospital of Hebei Medical University, The Second Affiliated Hospital of Baotou Medical College, Affiliated Hospital of Southwest Medical University, Sichuan Cancer Hospital and Research Institute, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Zhongda Hospital, The First Affiliated Hospital with Nanjing Medical University, West China Hospital, The First Affiliated Hospital of Soochow University, Jiangsu Province Hospital of Traditional Chinese Medicine, Shandong Provincial Hospital, Shanxi Provincial People's Hospital, Henan Provincial People's Hospital, Anyang Cancer Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
With the development of endoscopy, more and more patients with superficial esophageal squamous cell carcinoma (ESCC) receive endoscopic resection rather than traditional surgery. However, there is still no complete consensus on the risk factors for lymph node metastasis (LNM) and recurrence of ESCC after endoscopic resection. The existing curative resection criteria are strict to a certain extent, and a considerable number of patients are overtreated according to the current standard of additional treatment. Thus, we aim to conduct a multi-center retrospective and prospective study to construct a large cohort of ESCC based on the previously established multi-center collaborative research network and clinical big data, analyze the risk factors of LNM and recurrence in patients with early esophageal squamous cell carcinoma after ESD, establish an accurate and simple risk prediction model, and evaluate the discrimination efficiency of this model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From January 2015 to December 2020, no less than 1400 patients who received ESD treatment for early esophageal squamous cell carcinoma were expected to be included.
Key inclusion criteria (4 listed)
- Men and women, aged 18-85.
- ESD was performed for early (superficial) esophageal squamous cell carcinoma, and the indication was in line with domestic and foreign guidelines.
- The pathological stage after ESD was pT1a/pT1b.
- The effective follow-up time after ESD was ≥3 years, or recurrence or LNM occurred during the follow-up period.
Key exclusion criteria (6 listed)
- Esophageal chemoradiotherapy or esophageal surgery were performed before ESD.
- There is a history of carcinoma, early carcinoma, adenoma and other benign and malignant tumors of stomach and duodenum.
- Pathological data after ESD were incomplete.
- Combined with malignant tumors of other organs.
- Fragmented endoscopic mucosal resection (EMR), multi-loop mucosal resection (MBM) and other endoscopic non-monolithic resection techniques were used.
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 |
|---|---|---|
| observational studyobservational study, no intervention | Other | – |
Primary outcome
Noncurative Resection
Time frame: 2022-12 Complete the preliminary clinical study preparation. 2023-10 Complete patient data analysis and sorting. 2024-10 Construct an accurate evaluation system. 2025-10 Conduct validation analysis of the evaluation system.
Noncurative resection was defined as the presence of residual tumor or lymph node metastasis at the vertical margin of the lesion confirmed by pathology after surgery, or local recurrence, lymph node metastasis, or distant metastasis attributable to the primary tumor during follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 Early Esophageal Cancer, run by Changhai Hospital 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 4 inclusion and 6 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 23 Jul 2024. 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 Luowei Wang, Doctor (13901833088, wangluoweimd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noncurative Resection (time frame: 2022-12 Complete the preliminary clinical study preparation. 2023-10 Complete patient data analysis and sorting. 2024-10 Construct an accurate evaluation system. 2025-10 Conduct validation analysis of the evaluation system.). 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 23 Jul 2024.