China Early Esophageal Cancer Cohort | NCT06515964

Studies
China Early Esophageal Cancer Cohort

NCT06515964

Sponsor

Changhai Hospital

Status

Recruiting

Last Update Posted

Jul 23, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Early Esophageal Cancer

Interventions

observational study

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Jul 17, 2024

First Submission Date that Met QC Criteria

Jul 22, 2024

First Posted Date

Jul 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2024

Last Update Posted Date

Jul 23, 2024Actual

Name	Class
Lianshui People's Hospital	UNKNOWN
The second affiliated hospital of Xuzhou medical university	UNKNOWN
The second people's hospital of Nanyang	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
observational study	Other	observational study, no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luowei Wang, Doctor	Contact	13901833088		wangluoweimd@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changhai Hospital	Recruiting	Shanghai	Shanghai Municipality	200433	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D008722	Methods
D008919	Investigative Techniques