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

NCT ID: NCT04980352

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Response Prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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real world treatment by doctors

real world treatment by doctors

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age at diagnosis \<18
* refuse to enroll
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Wuhan TongJi Hospital

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wuhan Union Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan Li, Dr.

Role: CONTACT

+862788041911

Facility Contacts

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Sufei Wang, Dr.

Role: primary

+862783691785

Other Identifiers

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2019-1-12 V1.1

Identifier Type: -

Identifier Source: org_study_id

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