Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients

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: NCT04229121
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary:
Verify the Coincidence rate between Circulating tumor cells (CTCs) and tumor tissue or Circulating tumor DNA (ctDNA) of advanced NSCLC patients with Driver gene mutation

Condition or disease Intervention/treatment
Advanced NSCLC Circulating Tumor Cells Circulating Tumor DNA Other: nonintervention

Detailed Description:
  1. Enrich CTCs from advanced Non-Small Cell Lung Cancer (NSCLC) patients with Driver gene mutation, and detect the Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) fusion, ROS proto-oncogene receptor tyrosine kinase 1 (ROS1) fusion, RET proto-oncogene (RET) fusion and Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping by Lung cancer Polymerase Chain Reaction (PCR) panel kit, and verify the mutation coincidence rate between CTCs and tumor tissue.
  2. Enrich ctDNA from advanced NSCLC patients with Driver gene mutation, detect the EGFR mutation by PCR, and detect the ALK fusion, ROS1 fusion, RET fusion and MET 14 exon skipping by next generation sequencing (NGS), and compare the mutation coincidence rate between CTCs and ctDNA.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Driver gene mutation-positive
Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation positive.
Other: nonintervention
nonintervention

Driver gene mutation-negative
Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation negative.
Other: nonintervention
nonintervention




Primary Outcome Measures :
  1. Driver gene mutation frequency from CTCs of advanced NSCLC patients [ Time Frame: 6 months ]
    Analyze the driver gene mutation frequency in CTCs from advanced NSCLC patients with tumor tissue driver gene mutation

  2. The gene mutation coincidence rate between CTCs and tumor tissue sample [ Time Frame: 6 months ]
    Comparison the gene mutation coincidence rate between CTCs and tumor tissue sample


Secondary Outcome Measures :
  1. Driver gene mutation frequency from ctDNA of advanced NSCLC patients [ Time Frame: 6 months ]
    Analyze the driver gene mutation frequency in ctDNA from advanced NSCLC patients with tumor tissue driver gene mutation

  2. The gene mutation coincidence rate between CTCs and ctDNA [ Time Frame: 6 months ]
    Comparison the gene mutation coincidence rate between CTCs and ctDNA



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Histologially or cytologically proven diagnosis of advanced NSCLC
Criteria

Inclusion Criteria:

  1. Female or male, 18 years of age or older
  2. Histologically or cytologically proven diagnosis of advanced NSCLC patients without any target therapy or chemotherapy
  3. Able to get tumor tissue gene (EGFR/ALK/ROS1/RET/MET skipping) testing results by Lung cancer Polymerase Chain Reaction (PCR) panel kit carried out in hospital
  4. Signed and dated informed consent

Exclusion Criteria:

  1. Combine with other tumor type
  2. The investigator judges the situation that may affect the clinical search process and results

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): NCT04229121


Contacts
Layout table for location contacts
Contact: Yayi He, MD,PHD +862165115006 2250601@qq.com

Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
Layout table for investigator information
Principal Investigator: Yayi He, MD,PHD Shanghai Pulmonary Hospital, Tongji University

Publications:
Layout table for additonal information
Responsible Party: Caicun Zhou, Director Head of Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT04229121    
Other Study ID Numbers: CTC-FM
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplastic Cells, Circulating
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes