Multi-omics Study of Early-stage Lung Cancer With Distinct Phenotypes

Comprehensive Multi-Omics Analysis of Early-Stage Lung Cancer Exhibiting Distinct Phenotypes

The goal of this observational study is to investigate the multi-omics characterization early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on. The main questions it aims to answer are:

• What are the differences in pathogenesis of non-small cell lung cancer with different phenotypes explored by multi-omics?
• Whether differential genes lead to potential prognostic models and therapeutic targets? Participants will be followed up after surgery to answer prognosis: whether they have recurred, and the time to recurrence.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer; Multiple Primary Lung Cancers; Lung Cancer Associated With Cystic Airspaces

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Chen Chen; Phone Number: +8673185295188; Email: chenchen1981412@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The second Xiangya Hospital of Central South University
      • Contact: Ping Jiang; Phone Number: +8673185292476; Email: xy2gcpjiang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-small cell lung cancer with indication for surgery.

Description

Cohort 1: Multi-omics study in early-stage synchronous multiple primary lung cancer

Inclusion criteria:

1. Male or female patients:18-75 years old;
2. ECOG score:0-1;
3. Histopathologically confirmed TNM stage I-II NSCLC;
4. Considered multiple or solitary primary lung cancer by clinical criteria (Martini-Melamed criteria and ACCP criteria);
5. Good compliance, family members agree to cooperate to receive survival follow-up;
6. Understand and voluntarily sign the informed consent.

Exclusion criteria:

1. A history of previous or co-existing malignant tumors;
2. Systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment;
3. Refusal to participate in the study.

Cohort 2: Multi-omics study of lung cancer associated with cystic airspaces

Inclusion criteria:

1. Male or female patients:18-75 years old;
2. ECOG score:0-1;
3. Histopathologically confirmed TNM stage I-II NSCLC;
4. CT findings show solitary or multiple nodules with cystic airspaces.

Exclusion criteria:

1. A history of previous or co-existing malignant tumors;
2. Systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment;
3. Refusal to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Non-small cell lung cancer; Early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immune repertoire sequencing	From enrollment to the end of surgery for 3 years
DNA methylome sequencing	From enrollment to the end of surgery for 3 years
RNA sequencing	From enrollment to the end of surgery for 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Genomic sequencing	From enrollment to the end of surgery for 3 years
Metabolomics analysis	From enrollment to the end of surgery for 3 years
Radiomics analysis	From enrollment to the end of surgery for 3 years

Collaborators and Investigators

• Sponsor: Central South University

Publications and helpful links

General Publications

• Zhong WZ, Wang Q, Mao WM, Xu ST, Wu L, Shen Y, Liu YY, Chen C, Cheng Y, Xu L, Wang J, Fei K, Li XF, Li J, Huang C, Liu ZD, Xu S, Chen KN, Xu SD, Liu LX, Yu P, Wang BH, Ma HT, Yan HH, Yang XN, Zhou Q, Wu YL; ADJUVANT investigators. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Jan;19(1):139-148. doi: 10.1016/S1470-2045(17)30729-5. Epub 2017 Nov 21.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LYEC2024-0320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No