Perioperative and Postoperative Circulating Tumor Cell Monitoring in Different Stage of NSCLC

NCT07186855 | Completed

• 1 other identifier: LC2020L02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to enroll 500 non-small cell lung cancer patients at various stages and to employ this technology for CTC detection, with subsequent cytomorphological and chromosomal analysis of the isolated CTCs, and comprehensively assess the utility of this CTC monitoring technology in predicting postoperative recurrence, metastasis, and survival in non-small cell lung cancer patients across different stages.

Conditions

Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Two-Year Recurrence Status

  Time from surgery util recurrence

  Up to 2 years after surgery

Study Arms (2)

early-stage NSCLC

CTC detection will be conducted on 180 cases.

Other: Blood Sample Collection for CTC Detection

Advanced-Stage Non-Small Cell Lung Cancer

CTC detection will be conducted on 320 cases.

Other: Blood Sample Collection for CTC Detection

Interventions

Blood Sample Collection for CTC Detection OTHER

Blood Sample Collection for CTC Detection

Advanced-Stage Non-Small Cell Lung Cancer; early-stage NSCLC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 500 non-small cell lung cancer patients undergoing surgical treatment will be enrolled from the Department of Thoracic Surgery at the Cancer Hospital, Chinese Academy of Medical Sciences, and its affiliated centers.Among them, approximately 180 cases will be early-stage.

You may qualify if:

• (1) Age of the patient: ≥18 and ≤75 years; (2) No prior anticancer treatment before surgery; (3) No history of other tumors, past or concurrent; (4) Underwent radical surgery for lung cancer between November 2020 and October 2022; (5) Postoperative pathological diagnosis of non-small cell lung cancer, with staging between Ia and IIIb; (6) Able to comply with study requirements and has signed informed consent.

You may not qualify if:

• (1) Patients with non-small cell lung cancer who have received tumor-related treatments before surgery (including chemotherapy, radiotherapy, targeted therapy, and immunotherapy); (2) Patients with severe cardiac, pulmonary, hepatic, cerebral, or renal dysfunction who are unable to tolerate surgery; (3) Pregnant patients; (4) Patients with concurrent other malignancies; (5) Patients with severe underlying diseases that make them unable to tolerate surgery; (6) Patients with types of lung cancer other than non-small cell lung cancer or with secondary malignant tumors in the lung.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Nationa Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijingn, 100021, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• YOUSHAN MAO, MD

  NCC, CICAMS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 22, 2025
• Study Start: January 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 22, 2025

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)