Multi-dimensional Signatures for Precisely Predicting the Response and Prognosis of Lung Cancer Patients

Prognosis Clinical Trial

— Pred-lung  

Official title:

Multi-dimensional Signatures for Precisely Predicting the Response and Prognosis of Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980352
• Other study ID #: 2019-1-12 V1.1
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2021
• Source: Wuhan Union Hospital, China
• Contact: Yuan Li, Dr.
• Phone: +862788041911
• Email: liyuanpumc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to determine the clinical effectiveness of multi-dimensional signatures in predicting response and prognosis of lung cancer patients. The study is a multi-center perspective research of treatment planning for patients with lung cancer. To characterize clinical effectiveness, the progression-free survival (PFS) and overall survival (OS) impacts of multi-dimensional signatures will be estimated.

Description:

Multi-dimensional signatures, including NGS-based genotyping, and other essential detections such as immunohistochemistry (IHC), provides an opportunity to improve outcomes for patients by tailoring treatments to each individual's genomic profile. This is a multi-center single arm research study integrating multi-dimensional signatures into clinical decision-making for patients with lung cancer. The clinical effectiveness of multi-dimensional signatures is unknown in the real-world of clinics. To identify a counterfactual for Pred-lung approach, matching methods combined with administrative healthcare data will be used. The survival impacts of Pred-lung approach compared to usual care in matched controls will then be estimated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with locally-advanced or metastasis lung cancer
• Life expectancy > 3 months

Exclusion Criteria:

• Age at diagnosis <18
• refuse to enroll

Related Conditions & MeSH terms

• Lung Neoplasms
• Prognosis
• Response

Intervention

Other:
• real world treatment by doctors
real world treatment by doctors

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China	Renmin Hospital of Wuhan University, Wuhan TongJi Hospital, Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival	through study completion, an average of 6 months
Secondary	OS	Overall survival	through study completion, an average of 1 year