Multiomics Tumor Evolution Model of NSCLC

NCT05352035 | Recruiting

• 1 other identifier: 2021-I2M-5-002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; Multiomics analysis; Tumor evolution; Tumor immune microenvironment; Circulating tumor DNA; Radiomics; Prognostic model

Outcome Measures

Primary Outcomes (2)

• Disease-free survival (DFS)

  Time from randomization to disease recurrence or death from any cause.

  Through study completion, an average of 2 years

• Overall survival (OS)

  Time from randomization to death from any cause.

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• Relationship between translational biomarkers and clinical outcome

  Through study completion, an average of 2 years

Study Arms (1)

Prospective cohort

This cohort will enroll a total of 300 patients prospectively

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 who meet the eligibility criteria will be included consecutively.

You may qualify if:

• Age ≥ 18 years old;
• Early-stage NSCLC patients underwent radical surgical resection;
• Sufficient tumor tissue and blood sample for study use;
• Available clinical-pathologic data, imaging data and follow-up date;
• Written informed consent.

You may not qualify if:

• History of other malignant tumors;
• Evidence of distant metastasis before surgery;
• Insufficient tumor tissue or blood sample for study use;
• Clinical-pathologic data, imaging data or follow-up date is not available;
• Other judgments by the Investigator that the patient should not participate in the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Research Unit of Intelligence Diagnosis and treatment of early-stage non-small cell lung cancer, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue and blood samples

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

Study Officials

• Jun Wang

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Kezhong Chen, M.D.

CONTACT

+86-010-88326657; chenkezhong@pkuph.edu.cn

Wenxiang Wang

CONTACT

+86-010-88326657; wangwenxiang@stu.pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member of the Chinese Academy of Engineering

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: April 28, 2022
• Study Start: April 20, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)