Clinical trial NCT06699979: Multi-omics Study of Early-stage Lung Cancer with Distinct Phenotypes
Official title: Comprehensive Multi-Omics Analysis of Early-Stage Lung Cancer Exhibiting Distinct Phenotypes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Associated with Cystic Airspaces
Multiple Primary Lung Cancers
Non-Small Cell Lung Cancer
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer with indication for surgery.

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.


Eligibility 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.

Primary outcomes:
measure: Immune repertoire sequencing
timeFrame: From enrollment to the end of surgery for 3 years
measure: DNA methylome sequencing
timeFrame: From enrollment to the end of surgery for 3 years
measure: RNA sequencing
timeFrame: From enrollment to the end of surgery for 3 years
Secondary outcomes:
measure: Genomic sequencing
timeFrame: From enrollment to the end of surgery for 3 years
measure: Metabolomics analysis
timeFrame: From enrollment to the end of surgery for 3 years
measure: Radiomics analysis
timeFrame: From enrollment to the end of surgery for 3 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
citation: 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.