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

NCT05094882 | Unknown DMC

• 1 other identifier: ALMPILN
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma; Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; Intrapulmonary Lymph Nodes; Anatomical Location; Metastasis Pattern

Outcome Measures

Primary Outcomes (1)

• metastasis rate of group 11-13 LN

  metastasis rate of intrapulmonary lymph nodes (group 11-13 LN) in non-small cell lung cancer

  one month after surgery

Secondary Outcomes (1)

• detailed anatomical location

  immediately after surgery

Study Arms (5)

RUL

patients who recieved the resection of right upper lobe (RUL)

Procedure: pulmonary lobectomy

RML

patients who recieved the resection of right middle lobe ()

Procedure: pulmonary lobectomy

RLL

patients who recieved the resection of right lower lobe (RML)

Procedure: pulmonary lobectomy

LUL

patients who recieved the resection of left upper lobe (LUL)

Procedure: pulmonary lobectomy

LLL

patients who recieved the resection of left lower lobe (LLL)

Procedure: pulmonary lobectomy

Interventions

pulmonary lobectomy PROCEDURE

resection of lung lobe

LLL; LUL; RLL; RML; RUL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hong Hu

  Fudan University Affiliated Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hong hu

CONTACT

86-13512102066; huhong0997@163.com

Hong Hu

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 26, 2021
• Study Start: December 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: every 3 months after the study begin.

Locations

CN (1)