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

NCT ID: NCT06699979

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-29
• Study Completion Date: 2027-12-31

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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

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.

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Chen Chen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Chen

Role: CONTACT

chenchen1981412@csu.edu.cn

+8673185295188

Facility Contacts

Ping Jiang

Role: primary

xy2gcpjiang@163.com

+8673185292476

References

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.

Reference Type: BACKGROUND

PMID: 29174310 (View on PubMed)

Other Identifiers

LYEC2024-0320

Identifier Type: -

Identifier Source: org_study_id