NCT03764917

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

December 3, 2018

Last Update Submit

March 22, 2020

Conditions

Non-small Cell Lung Cancer

Keywords

NGSRNAseq

Outcome Measures

Primary Outcomes (1)

  • numbers of immune cells

    detecting numbers of immune cells before first-line chemotherapy, after two cycles chemotherapy and after disease progression

    24 months

Secondary Outcomes (1)

  • numbers of tumor mutations

    24 months

Interventions

TimeOTHER

Different detecting time

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • EGFR mutant positive Alk mutant positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

  • 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.

    PMID: 34093873DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Time

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Yayi He, MD, PHD

    Shanghai Pulmonary Hospital, Tongji University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Caicun Zhou

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 5, 2018

Study Start

December 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

CN(1)