Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)

NCT ID: NCT04923802

Last Updated: 2024-03-08

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

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-24

Study Completion Date

2021-12-31

Brief Summary

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This multicenter prospective observational and exploratory study aims to develop and validate a novel multi-omics-based computational method for neoantigen prediction in non-small cell lung cancer (NSCLC), and discover biomarkers for evaluation of PD-1/PD-L1 inhibitor's efficacy in patients of advanced NSCLC.

Detailed Description

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Tumor tissues and blood samples from about 400 patients with non-small-cell lung cancer (NSCLC) will be collected for the study, which will be subject to NGS-based genomic, transcriptomic, and methylomic profiling in order to construct a multi-omics landscape of NSCLC. These multi-omics data will be used to construct and validate a novel computational method for neoantigen prediction. Additionally, biomarkers will be explored for prognosis and patient stratification, as well as for evaluation of PD-1/PD-L1 inhibitor treatment efficacy in patients of advanced NSCLC.

Conditions

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Non-small Cell Lung Cancer Neoantigen Next-generation Sequencing Biomarker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with stage I-IV non-small cell lung cancer(with no restriction of age, gender, or smoking history)
* Patients in the group will be allowed to collect whole blood and tissue samples at specific time points
* Eastern Cooperative Oncology Group Performance Status of 0-1 within 28 days prior to registration
* No previous systemic anti-tumor therapy
* Signed informed consent

Exclusion Criteria

* Active or history of autoimmune disease or immune deficiency
* Patients with serious mental disease
* Prior allogeneic stem cell or solid organ transplantation
* Pregnant or lactating women
* Patients who cannot obtain tumor tissue samples and / or whole blood
* Patients with history of blood transfusion within half a year
* Patients with any other malignancy diagnosed within 5 years
* Received systemic anti-tumor therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinqiao Hospital of Chongqing

OTHER

Sponsor Role collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role collaborator

People's Hospital of Chongqing

OTHER

Sponsor Role collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role collaborator

Guizhou Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Shaanxi Provincial Cancer Hospital

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

Affiliated Cancer Hospital of Shantou University Medical College

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

GeneCast Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bo Zhu

Role: PRINCIPAL_INVESTIGATOR

Xinqiao Hospital of Chongqing

Locations

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Second Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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MOTIVATION

Identifier Type: -

Identifier Source: org_study_id

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