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

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04980352
Collaborator
Renmin Hospital of Wuhan University (Other), Wuhan TongJi Hospital (Other), Wuhan University (Other)
200
1
47.9
4.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: real world treatment by doctors

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multi-dimensional Signatures for Precisely Predicting the Response and Prognosis of Lung Cancer Patients
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2024

Outcome Measures

Primary Outcome Measures

  1. PFS [through study completion, an average of 6 months]

    Progression-free survival

Secondary Outcome Measures

  1. OS [through study completion, an average of 1 year]

    Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with locally-advanced or metastasis lung cancer

  • Life expectancy > 3 months

Exclusion Criteria:
  • Age at diagnosis <18

  • refuse to enroll

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wuhan Union Hospital Wuhan Hubei China 430000

Sponsors and Collaborators

  • Wuhan Union Hospital, China
  • Renmin Hospital of Wuhan University
  • Wuhan TongJi Hospital
  • Wuhan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wuhan Union Hospital, China
ClinicalTrials.gov Identifier:
NCT04980352
Other Study ID Numbers:
  • 2019-1-12 V1.1
First Posted:
Jul 28, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wuhan Union Hospital, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2021