Value of Pleural Lavage Cytology in Resectable Esophageal Carcinoma Eastern Cooperative Thoracic Oncology Projects 2005, ECTOP-2005) (ECTOP-2005)

July 12, 2023 updated by: Haiquan Chen, Fudan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Bin Li, MD
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • The First Affiliated Hospital of USTC
        • Contact:
          • Xinyu Mei, MD
    • Hebei
      • Shijia Zhuang, Hebei, China
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
          • Xinjian Xu, MD
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Jianjun Wang
    • Jiangsu
      • Nantong, Jiangsu, China
        • Not yet recruiting
        • Nantong Tumor Hospital
        • Contact:
          • Yihui Fan, MD
      • Nantong, Jiangsu, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Nantong University
        • Contact:
          • Yiming Xu, MD
      • Taixing, Jiangsu, China
        • Recruiting
        • Taixing People's Hospital
        • Contact:
          • Xiaoxiang Xi, MD
      • Taizhou, Jiangsu, China
        • Not yet recruiting
        • Taizhou People's Hospital
        • Contact:
          • Jiangfeng Shen, MD
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Not yet recruiting
        • Shaanxi Provincial Cancer Hospital
        • Contact:
          • Xi Zhang, MD
    • Shannxi
      • Xi'an, Shannxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Zhuoqi Jia, MD
    • Tianjin
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute
        • Contact:
          • Peng Tang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with esophageal cancer

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • severe major organ dysfunction (American society of anesthesiologisits score >3 )
  • patients underwent ESD or EMR
  • pleural lavage is unavailable due to adhesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
July 2022 to July 2023

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time period from date of surgery to the date of death
Time Frame: July 2022 to July 2026
value of pleural lavage cytology in predict patient survival
July 2022 to July 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Haiquan Chen, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECTOP-2005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

individual participant data could be shared after the recruitment of all 385 patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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