Multiomics Tumor Evolution Model of NSCLC

Sponsor

Peking University People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05352035

Collaborator

Research Unit of Intelligence Diagnosis and treatment of early-stage non-small cell lung cancer, Chinese Academy of Medical Sciences (Other)

300

Enrollment

Location

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer

Detailed Description

Lung cancer is the leading cause of cancer-related death globally. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and surgery is still the main treatment strategy. This study will 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multiomics Study of Tumor Evolution Characteristics and Prognostic Model in Early-stage Non-small Cell Lung Cancer

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Prospective cohort This cohort will enroll a total of 300 patients prospectively

Outcome Measures

Primary Outcome Measures

Disease-free survival (DFS) [Through study completion, an average of 2 years]
Time from randomization to disease recurrence or death from any cause.
Overall survival (OS) [Through study completion, an average of 2 years]
Time from randomization to death from any cause.

Secondary Outcome Measures

Relationship between translational biomarkers and clinical outcome [Through study completion, an average of 2 years]
To evaluate if the translational biomarkers can be prediction tools for the clinical outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing		China

Sponsors and Collaborators

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