Value of Pleural Lavage Cytology in Resectable Esophageal Carcinoma Eastern Cooperative Thoracic Oncology Projects 2005, ECTOP-2005)
ECTOP-2005
A Prospective Study for Pleural Lavage Cytology in Patients With Esophageal Cancer
1 other identifier
observational
385
1 country
11
Brief Summary
Disease recurrence and metastasis are common after curative treatment for patients with esophageal cancer. Thus, it is important to identify the risk factors to predict disease recurrence and metastasis. Pleural lavage cytology (PLC) is reported to be associated with disease recurrence and patient survival in lung cancer, but the value is unclear in esophageal cancer. The aim of this study is to evaluate the value of PLC in esophageal cancer patient in terms of frequencies, association with patient survival, and efficacy of postoperative treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedStudy Start
First participant enrolled
July 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedJuly 13, 2023
July 1, 2023
2 years
June 22, 2022
July 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients who had positive pleural lavage cytology
Frequency of positive pleural lavage cytology in resectable esophageal squamous cell carcinoma
July 2022 to July 2023
Secondary Outcomes (1)
Time period from date of surgery to the date of death
July 2022 to July 2026
Interventions
pleural lavages before tumor resection and after tumor resecion, respectively
Eligibility Criteria
patients with esophageal cancer
You may qualify if:
- esophageal cancer with histological confirmation before treatment.
- resectable esophageal cancer with clinical T1-4a/N0-3/M0 staging
- potential R0 resection
- no history of other malignancies
You may not qualify if:
- severe major organ dysfunction (American society of anesthesiologisits score \>3 )
- patients underwent ESD or EMR
- pleural lavage is unavailable due to adhesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (11)
The First Affiliated Hospital of USTC
Hefei, Anhui, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The Second Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Taixing People's Hospital
Taishing, Jiangsu, China
Taizhou People's Hospital
Taizhou, Jiangsu, China
Shaanxi Provincial cancer Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China
Tianjin Medical University Cancer Institute
Tianjin, Tianjin Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haiquan Chen, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fudan University Shanghai Cancer Center
Study Record Dates
First Submitted
June 22, 2022
First Posted
July 5, 2022
Study Start
July 18, 2022
Primary Completion
July 1, 2024
Study Completion (Estimated)
July 1, 2027
Last Updated
July 13, 2023
Record last verified: 2023-07