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Multiplex Analysis of Circulating Tumor DNA

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ClinicalTrials.gov Identifier: NCT03301961
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital

Brief Summary:
Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients

Condition or disease
Carcinoma Non-small-cell Lung Cancer Lung Neoplasm

Detailed Description:

Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.

Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Clinical Applications of Multiplex Analysis of Circulating Tumor DNA Biomarkers in Lung Cancer Patients
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer [ Time Frame: 12 months ]
  2. The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection [ Time Frame: 36 months ]
  3. Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches [ Time Frame: 36 months ]

Biospecimen Retention:   Samples With DNA
A series of lung cancer patients plasma before and after surgery


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patient are found nodules in pulmonary and prepare for surgery
Criteria

Inclusion Criteria:

  1. Sign informed consent and consent to participate in this study;
  2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion Criteria:

  1. Malignant tumor history within the past 5 years;
  2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
  3. No matching tissue or blood samplesUnqualified blood samples
  4. Lesion is pure ground glass opacity.

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): NCT03301961


Contacts
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Contact: Kezhong Chen, MD (+86)13488752289 mdkzchen@163.com
Contact: Heng Zhao, MD (+86)13683139396 zhaohengzhaoheng@126.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Kezhong Chen, M.D.    +8613488752289    mdkzchen@163.com   
Principal Investigator: Jun Wang, M.D.         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Director: Kezhong Chen, MD Peking University People's Hospital
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Responsible Party: Jun Wang, Chief,Thoracic Surgery Service, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03301961    
Other Study ID Numbers: PTHO1701
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Wang, Peking University People's Hospital:
Circulating Tumor DNA
Early diagnosis
Surveillance
Methylation
Somatic mutation
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases