NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

November 7, 2019 updated by: Lu Shun, Shanghai Chest Hospital

A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients in shanghai chest hospital

Description

Inclusion Criteria:

  • Participant aged 18 or above, and gender unrestricted
  • Individual with pathologically diagnosed lung cancer

Exclusion Criteria:

  • Patients with concomitant other tumors
  • Individual with severe cardiopulmonary insufficiency and hypoproteinemia
  • Women who were pregnant and were during their lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: through the whole study period, an average of 3 year
PFS refers to the time from initial treatment to the time of disease progression or death
through the whole study period, an average of 3 year
Tumor Mutational Burden (TMB)
Time Frame: halfway of the study, an average of 1.5 year
TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases
halfway of the study, an average of 1.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other biomarkers
Time Frame: halfway of the study, an average of 1.5 year
The distribution and clinical application value of molecular biomarkers such as Neoantigen, MSI and LOH in Chinese lung cancer patients
halfway of the study, an average of 1.5 year
Clonality
Time Frame: halfway of the study, an average of 1.5 year
The tumor clonality in Chinese lung cancer patients
halfway of the study, an average of 1.5 year
Overall survival (OS)
Time Frame: through the whole study period, an average of 3 year
OS refers to the time from the patient entering into the group to the time of death
through the whole study period, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiChest0015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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