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

Central South University

Status: Enrolling

Conditions: Lung Cancer Associated with Cystic Airspaces; Multiple Primary Lung Cancers; Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06699979

LYEC2024-0320

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

300 participants in 1 patient group

Non-small cell lung cancer

Description:

Early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on.