Esophageal CancerECTOP-2005NCT05443841
Value of Pleural Lavage Cytology in Resectable Esophageal Carcinoma Eastern Cooperative Thoracic Oncology Projects 2005, ECTOP-2005)
An observational study of Esophageal Cancer, run by Fudan University at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- pleural lavage
- How many people
- 385 participants
- Where
- 11 sitesChina
- Study dates
- 18 Jul 2022to 1 Jul 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with esophageal cancer
Who may be able to join
- 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
Who cannot join
- severe major organ dysfunction (American society of anesthesiologisits score >3 )
- patients underwent ESD or EMR
- pleural lavage is unavailable due to adhesions
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
The First Affiliated Hospital of USTC
Hefei, Anhui
Xinyu Mei, MD
- Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu
Yihui Fan, MD
- Not yet recruiting
The Second Affiliated Hospital of Nantong University
Nantong, Jiangsu
Yiming Xu, MD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Bin Li, MD
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Xinjian Xu, MD
- Recruiting
Taixing People's Hospital
Taishing, Jiangsu
Xiaoxiang Xi, MD
- Not yet recruiting
Taizhou People's Hospital
Taizhou, Jiangsu
Jiangfeng Shen, MD
- Not yet recruiting
Tianjin Medical University Cancer Institute
Tianjin, Tianjin Municipality
Peng Tang, MD
- Not yet recruiting
Shaanxi Provincial cancer Hospital
Xi'an, Shaanxi
Xi Zhang, MD
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi
Zhuoqi Jia, MD
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Jianjun Wang
About this study
Official title: A Prospective Study for Pleural Lavage Cytology in Patients With Esophageal Cancer
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.
Read the detailed description
Pleural lavage cytology will be performed before esophageal resection, and after resection, respectively. Frequency of positive pleural lavage cytology will be determined, and the value of pleural lavage cytology for patients with resectable esophageal cancer will be studied.
- Conditions
- Esophageal Cancer
- Being tested
- pleural lavage
- Keywords
- Squamous cell carcinoma, Esophagectomy, Pleural Lavage
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pleural lavageOther
pleural lavages before tumor resection and after tumor resecion, respectively
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who had positive pleural lavage cytology
Frequency of positive pleural lavage cytology in resectable esophageal squamous cell carcinoma
Measured: July 2022 to July 2023
Secondary outcomes (1)
Time period from date of surgery to the date of death
value of pleural lavage cytology in predict patient survival
Measured: July 2022 to July 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start18 Jul 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2027 (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 Fudan UniversityThe 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
- Prospective
- Enrolment
- 385 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Haiquan Chen, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443841
- Sponsor's protocol ID
- ECTOP-2005
- Acronym
- ECTOP-2005
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data could be shared after the recruitment of all 385 patients
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for Pleural Lavage Cytology in Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05443841
- Acronym / sponsor ID
- ECTOP-2005 / ECTOP-2005
- Conditions
- Esophageal Cancer
- Keywords
- Squamous cell carcinoma, Esophagectomy, Pleural Lavage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 5 Jul 2022 (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.
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.
Detailed description
Pleural lavage cytology will be performed before esophageal resection, and after resection, respectively. Frequency of positive pleural lavage cytology will be determined, and the value of pleural lavage cytology for patients with resectable esophageal cancer will be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with esophageal cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- severe major organ dysfunction (American society of anesthesiologisits score >3 )
- patients underwent ESD or EMR
- pleural lavage is unavailable due to adhesions
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 |
|---|---|---|
| pleural lavagepleural lavages before tumor resection and after tumor resecion, respectively | Other | – |
Primary outcome
number of patients who had positive pleural lavage cytology
Time frame: July 2022 to July 2023
Frequency of positive pleural lavage cytology in resectable esophageal squamous cell carcinoma
1 secondary outcome
Time period from date of surgery to the date of death
Time frame: July 2022 to July 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: Undecided. individual participant data could be shared after the recruitment of all 385 patients
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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.
Haiquan Chen, MD principal investigator
Fudan University
11 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 Fudan University at 11 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Li, MD (086-64175590-82500, lb0256327@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients who had positive pleural lavage cytology (time frame: July 2022 to July 2023). 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 13 Jul 2023.