Multiomics Tumor Evolution Model of NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05352035
• Other study ID #: 2021-I2M-5-002
• Status: Not yet recruiting
• Start date: May 2022
• Est. completion date: September 2026

Study information

• Verified date: April 2022
• Source: Peking University People's Hospital
• Contact: Kezhong Chen, M.D.
• Phone: +86-010-88326657
• Email: chenkezhong[@]pkuph.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old;

2. Early-stage NSCLC patients underwent radical surgical resection;

3. Sufficient tumor tissue and blood sample for study use;

4. Available clinical-pathologic data, imaging data and follow-up date;

5. Written informed consent.

Exclusion Criteria:

1. History of other malignant tumors;

2. Evidence of distant metastasis before surgery;

3. Insufficient tumor tissue or blood sample for study use;

4. Clinical-pathologic data, imaging data or follow-up date is not available;

5. Other judgments by the Investigator that the patient should not participate in the study.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	Time from randomization to disease recurrence or death from any cause.	Through study completion, an average of 2 years
Primary	Overall survival (OS)	Time from randomization to death from any cause.	Through study completion, an average of 2 years
Secondary	Relationship between translational biomarkers and clinical outcome	To evaluate if the translational biomarkers can be prediction tools for the clinical outcomes.	Through study completion, an average of 2 years