Esophageal CancerNCT03415815
An Observational Study to Evaluate Lymph Metastases and Prognoses of the Patients With Esophageal Cancer
An observational study of Esophageal Cancer, run by Henan Cancer Hospital at 10 sites in China.
Trial summary
The real-world observational study was designed to explore lymph metastases and prognoses of the Chinese patients with thoracic T1-T3 esophageal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 3,673 participants
- Where
- 10 sitesChina
- Study dates
- 12 Dec 2017to 30 Apr 2018
- 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: Pathologically diagnosed Chinese patients with thoracic T1-T3 esophageal cancer who received radical resection of esophageal cancer
Who may be able to join
- Patients >= 18 years old;
- Patients who received radical resection of esophageal cancer;
- Pathologically diagnosed patients with thoracic T1-T3 esophageal cancer after surgeries;
Who cannot join
- Patients who received upper gastrointestinal surgeries;
- Patients with second primary tumors;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Deruo Liu, PhD
- Recruiting
China PLA General Hospital
Beijing, Beijing Municipality, 100853
Yang Liu, PhD
- Recruiting
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, 610041
Lunxu Liu, PhD
- Recruiting
First Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, 310003
Jian Hu, PhD
- Recruiting
Jiangsu cancer hospital
Nanjing, Jiangsu, 210009
Lin Xu, PhD
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Heng Zhao, PhD
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Xun Zhang, PhD
- Recruiting
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, 430030
Yin Li, PhD
- Recruiting
Xi'an Tangdu Hospital
Xi'an, Shaanxi, 610041
Xiaofei Li, PhD
- Recruiting
Henan cancer hospital
Zhengzhou, Henan, 450008
Yin Li, PhD
About this study
Official title: A Real-world Observational Study to Evaluate Lymph Metastases and Prognoses of the Chinese Patients With Thoracic T1-T3 Esophageal Cancer
The real-world observational study was designed to explore lymph metastases and prognoses of the Chinese patients with thoracic T1-T3 esophageal cancer
Read the detailed description
This trial is a real-world non-interventional observational study. The Chinese patients with thoracic T1-T3 esophageal cancer enrolled from Jan.1999 to Jun.2017 were included and the study data on pathologically diagnosed patient demographic/tumor biological characteristics were collected to evaluate the relevance of lymph metastases and prognoses of the subjects.
- Conditions
- Esophageal Cancer
- Being tested
- Surgeries
- Keywords
- Chinese, real-world evidences, T1-T3 esophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeriesProcedure or surgery
Radical resection of esophageal cancer
| Study group | Role | What they receive |
|---|---|---|
| T1-T3 esophageal cancer | Pathologically diagnosed patients with T1-T3 esophageal cancer who received surgeries Receives: Procedure: Surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1999 - 2017
Secondary outcomes (1)
Impact factors of lymph metastases
Impact factors of lymph metastases
Measured: 1999 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start12 Dec 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- 3,673 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, Yin Li, Henan Cancer Hospital
- Investigators
- Yin Li, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415815
- Sponsor's protocol ID
- HenanEC
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Observational Study to Evaluate Lymph Metastases and Prognoses of the Chinese Patients With Thoracic T1-T3 Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03415815
- Acronym / sponsor ID
- HenanEC
- Conditions
- Esophageal Cancer
- Keywords
- Chinese, real-world evidences, T1-T3 esophageal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,673 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 30 Jan 2018 (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.
The real-world observational study was designed to explore lymph metastases and prognoses of the Chinese patients with thoracic T1-T3 esophageal cancer
Detailed description
This trial is a real-world non-interventional observational study. The Chinese patients with thoracic T1-T3 esophageal cancer enrolled from Jan.1999 to Jun.2017 were included and the study data on pathologically diagnosed patient demographic/tumor biological characteristics were collected to evaluate the relevance of lymph metastases and prognoses of the subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T1-T3 esophageal cancer | – | Procedure: SurgeriesPathologically diagnosed patients with T1-T3 esophageal cancer who received surgeries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically diagnosed Chinese patients with thoracic T1-T3 esophageal cancer who received radical resection of esophageal cancer
Key inclusion criteria (3 listed)
- Patients >= 18 years old;
- Patients who received radical resection of esophageal cancer;
- Pathologically diagnosed patients with thoracic T1-T3 esophageal cancer after surgeries;
Key exclusion criteria (2 listed)
- Patients who received upper gastrointestinal surgeries;
- Patients with second primary tumors;
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 |
|---|---|---|
| SurgeriesRadical resection of esophageal cancer | Procedure or surgery | T1-T3 esophageal cancer |
Primary outcome
Numbers of lymph nodes and percentages of patients with surgeries
Time frame: 1999 - 2017
Numbers of lymph nodes and percentages of patients with surgeries in the patients with thoracic T1-T3 esophageal cancer
1 secondary outcome
Impact factors of lymph metastases
Time frame: 1999 - 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- 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.
Yin Li principal investigator
Henan Cancer Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Henan Cancer Hospital at 10 sites 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 2 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 Haiying Yang (0086-10-62680809, celineyang@linkdoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of lymph nodes and percentages of patients with surgeries (time frame: 1999 - 2017). 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 30 Jan 2018.