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

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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

Tracking Information
First Submitted Date October 23, 2019
First Posted Date November 12, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date August 30, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2019)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 7, 2019)
  • 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
  • Clonality [ Time Frame: halfway of the study, an average of 1.5 year ]
    The tumor clonality in Chinese lung cancer patients
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
Official Title A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients in shanghai chest hospital
Condition Lung Neoplasms
Intervention Other: The method of gene mutation detection
All samples were detected by large-panel, whereas some of which were also detected by WES.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 7, 2019)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Niu Xiaomin 021-22200000-3403 ar_tey@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04159337
Other Study ID Numbers ShanghaiChest0015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Lu Shun, Shanghai Chest Hospital
Study Sponsor Shanghai Chest Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Shanghai Chest Hospital
Verification Date November 2019