NGS Combined With RNAseq on Tumor Immune Escape in NSCLC

Study on the Effect of NGS Combined With RNAseq on Tumor Immune Escape in Advanced Non-small Cell Lung Cancer EGFR and ALK Mutant Negative Patients

Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Time

Detailed Description

Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq. Detecting non-small cell lung cancer patient NGS and RNAseq data before first-line chemotherapy, after two cycles chemotherapy and after disease progression.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Pulmonary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy Without EGFR and Alk mutation

Description

Inclusion Criteria:

Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy

Exclusion Criteria:

EGFR mutant positive Alk mutant positive

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numbers of immune cells	detecting numbers of immune cells before first-line chemotherapy, after two cycles chemotherapy and after disease progression	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numbers of tumor mutations	detecting numbers of tumor mutations before first-line chemotherapy, after two cycles chemotherapy and after disease progression	24 months

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Principal Investigator: Yayi He, MD, PHD, Shanghai pulmonary hospital, Tongji University

Publications and helpful links

General Publications

• He Y, Chen L, Zhao L, Dang S, Liu G, Sasada S, Ma PC, van Zandwijk N, Rosell R, Popper HH, Wang H, Jiang M, Guo H, Liu X, Chen S, Zhang X, Xu M, Zhu B, Liu M, Zhou C. Genomic and transcriptional alterations in first-line chemotherapy exert a potentially unfavorable influence on subsequent immunotherapy in NSCLC. Theranostics. 2021 May 13;11(14):7092-7109. doi: 10.7150/thno.58039. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: RNAseq; NGS
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: YS2018-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No