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

NCT06699979 | Recruiting

• 1 other identifier: LYEC2024-0320
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Primary Lung Cancers; Non-Small Cell Lung Cancer; Lung Cancer Associated With Cystic Airspaces

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• A history of previous or co-existing malignant tumors;
• 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;
• Refusal to participate in the study.
• Cohort 2: Multi-omics study of lung cancer associated with cystic airspaces
• Male or female patients:18-75 years old;
• ECOG score:0-1;
• Histopathologically confirmed TNM stage I-II NSCLC;
• CT findings show solitary or multiple nodules with cystic airspaces.
• A history of previous or co-existing malignant tumors;
• 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;
• Refusal to participate in the study.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29174310 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue, adjacent normal tissue, peripheral blood cells, and plasma samples were collected from each patient.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chen Chen

CONTACT

+8673185295188; chenchen1981412@csu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 21, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)