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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159337
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Lu Shun, Shanghai Chest Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Lung Neoplasms Other: The method of gene mutation detection

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: The method of gene mutation detection
    All samples were detected by large-panel, whereas some of which were also detected by WES.


Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Clonality [ Time Frame: halfway of the study, an average of 1.5 year ]
    The tumor clonality in Chinese lung cancer patients

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients in shanghai chest hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159337


Contacts
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Contact: Niu Xiaomin 021-22200000-3403 ar_tey@hotmail.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Niu Xiaomin       ar_tey@hotmail.com   
Sponsors and Collaborators
Shanghai Chest Hospital
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Responsible Party: Lu Shun, Chief physician, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT04159337    
Other Study ID Numbers: ShanghaiChest0015
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases