Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in NSCLC (ECTOP-1010) (ALMPILN)

July 18, 2023 updated by: Haiquan Chen, Fudan University

Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in Non-small Cell Lung Cancer: a Multi-center, Prospective Observational Clinical Trial

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1010. Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes (Group 11-13) in Non-small Cell Lung Cancer: a Multi-center, Prospective observational Clinical Trial

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients would be evaluated whether meet the criteria as clinical stage T1 non-small Cell Lung Cancer. Then, he/she would receive lobectomy. Finally, the detailed anatomical location of group 11-13 would be recorded immediately after surgery and their metastasis pattern would be explored in the follow-up period.

Study Type

Observational

Enrollment (Estimated)

500

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 Backup

  • Name: Hong Hu

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Center
        • Contact:

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with stage T1 peripheral non-small cell lung cancer (NSCLC) undergoing radical lobectomy

Description

Inclusion Criteria:

  1. Preoperative examination showed patients with clinical T1 peripheral non-small cell lung cancer (NSCLC);
  2. The lesion is located in a single lung segment or between two adjacent lung segments;
  3. Perform radical lobectomy;
  4. The preoperative examination did not reveal unresectable lymph nodes;
  5. Have not received any other tumor-related treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) before surgery;
  6. No malignant tumor history;
  7. No contraindications to surgery (ECOG score 0-1 points);

Exclusion Criteria:

  1. Pathology revealed patients with non-T1 stage non-small cell lung cancer (NSCLC);
  2. Radical lobectomy is not performed;
  3. Acception of any anti-tumor treatment before surgery (excluding Chinese medicine treatment);
  4. Refused to enter the group or asked to leave the group.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RUL
patients who recieved the resection of right upper lobe (RUL)
Procedure: pulmonary lobectomy
resection of lung lobe
RML
patients who recieved the resection of right middle lobe ()
Procedure: pulmonary lobectomy
resection of lung lobe
RLL
patients who recieved the resection of right lower lobe (RML)
Procedure: pulmonary lobectomy
resection of lung lobe
LUL
patients who recieved the resection of left upper lobe (LUL)
Procedure: pulmonary lobectomy
resection of lung lobe
LLL
patients who recieved the resection of left lower lobe (LLL)
Procedure: pulmonary lobectomy
resection of lung lobe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metastasis rate of group 11-13 LN
Time Frame: one month after surgery
metastasis rate of intrapulmonary lymph nodes (group 11-13 LN) in non-small cell lung cancer
one month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detailed anatomical location
Time Frame: immediately after surgery
number of group 11-13 intrapulmonary lymph nodes in Non-small cell lung cancer and their detailed anatomical location
immediately after surgery

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Hong Hu, Fudan University Affiliated Shanghai Cancer Center

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)

December 1, 2021

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALMPILN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.

IPD Sharing Time Frame

every 3 months after the study begin.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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