NCT03415815

Brief Summary

The real-world observational study was designed to explore lymph metastases and prognoses of the Chinese patients with thoracic T1-T3 esophageal cancer

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,673

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

January 11, 2018

Last Update Submit

January 23, 2018

Conditions

Esophageal Cancer

Keywords

Chinese, real-world evidences, T1-T3 esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Numbers of lymph nodes and percentages of patients with surgeries

    Numbers of lymph nodes and percentages of patients with surgeries in the patients with thoracic T1-T3 esophageal cancer

    1999 - 2017

Secondary Outcomes (1)

  • Impact factors of lymph metastases

    1999 - 2017

Other Outcomes (4)

  • Effects of lymph metastases on overall survival

    1999 - 2017

  • Effects of the numbers of lymph nodes on overall survival

    1999 - 2017

  • Effects of surgeries on the percentages of the patients with esophageal cancer who received lymphadenectomy

    1999 - 2017

  • +1 more other outcomes

Study Arms (1)

T1-T3 esophageal cancer

Pathologically diagnosed patients with T1-T3 esophageal cancer who received surgeries

Procedure: Surgeries

Interventions

SurgeriesPROCEDURE

Radical resection of esophageal cancer

T1-T3 esophageal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pathologically diagnosed Chinese patients with thoracic T1-T3 esophageal cancer who received radical resection of esophageal cancer

You may qualify if:

  • Patients \>= 18 years old;
  • Patients who received radical resection of esophageal cancer;
  • Pathologically diagnosed patients with thoracic T1-T3 esophageal cancer after surgeries;

You may not qualify if:

  • Patients who received upper gastrointestinal surgeries;
  • Patients with second primary tumors;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

China PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Henan cancer hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Tongji Hospital Affiliated to Huazhong Technology Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Jiangsu cancer hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Xi'an Tangdu Hospital

Xi'an, Shaanxi, 610041, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Huaxi Hospital Affiliated to Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300051, China

RECRUITING

First Hospital Affiliated to Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Yin Li

    Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiying Yang

CONTACT

0086-10-62680809celineyang@linkdoc.com

Chunya Chen

CONTACT

0086-10-62680809violazhang@linkdoc.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 30, 2018

Study Start

December 12, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)