We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696525
Recruitment Status : Unknown
Verified May 2018 by Jun Wang, Peking University People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2016
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
San Valley Biotechnology Incorporated
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.

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

Detailed Description:

Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients.

We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 145 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Stage ⅢA Non-small-cell Lung Cancer Patients
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers [ Time Frame: 4 years ]
  2. The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample [ Time Frame: 1 year ]
  3. Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis [ Time Frame: 4 years ]
  4. Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis [ Time Frame: 4 years ]
  5. CtDNA predictive value between locoregional recurrence and distant metastasis [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA

Fresh tumor tissue, urine samples and blood samples were collected from each patient.

Time:Preoperative, 3 days and 3、6、12、18、24、30、36 months after surgery.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Histologically confirmed stage ⅢA non-small cell lung cancer patients who have the same driver mutation in tumor tissue and circulating tumor DNA(blood or urine)
Criteria

Inclusion Criteria:

  • Aged 18 to 80 years
  • Undergo radical surgery（R0 resection）
  • Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer
  • Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue
  • Blood or urine circulating tumor detect the driver mutation detected in tumor tissue
  • Patients must have given written informed consent

Exclusion Criteria:

  • Unable to comply with the study procedure
  • Malignant tumor history within the past 5 years
  • Patients who received any treatment prior to resection
  • R1 or R2 resection
  • Coexisting small cell lung cancer
  • Received target drug therapy after surgery
  • Unqualified blood or urine samples
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02696525


Contacts
Layout table for location contacts
Contact: Kezhong Chen, M.D. （+86）13488752289 mdkzchen@163.com
Contact: Lixin Zhou, M.D. （+86）13811264336 zhoulixin04@sina.com

Locations
Layout table for location information
China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Contact: Kezhong Chen, M.D.    +8613488752289    mdkzchen@163.com   
Contact: Lixin Zhou, M.D.    +8613811264336    zhoulixin04@sina.com   
Principal Investigator: Jun Wang, M.D.         
Sub-Investigator: Fan Yang, M.D.         
Sub-Investigator: Kezhong Chen, M.D.         
Sub-Investigator: Lixin Zhou, M.D.         
China, Guangdong
Guang Dong General Hospital, Thoracic Surgery
Guangzhou, Guangdong, China, 510080
Contact: Xuening Yang, M.D.         
Contact: Wenzhao Zhong, M.D.         
Principal Investigator: Yilong Wu, M.D.         
Sub-Investigator: Xuening Yang, M.D.         
Sub-Investigator: Wenzhao Zhong, M.D.         
China, Jiangsu
Jiang Su Cancer Hospital
Nanjing, Jiangsu, China, 210009
Contact: Feng Yin, M.D.         
Principal Investigator: Lin Xu, M.D.         
Sub-Investigator: Feng Yin, M.D.         
Sponsors and Collaborators
Peking University People's Hospital
San Valley Biotechnology Incorporated
Investigators
Layout table for investigator information
Principal Investigator: Jun Wang, M.D. Peking University People's Hospital
Study Chair: Yilong Wu, M.D. Guang Dong General Hospital
Study Director: Lin Xu, M.D. Jiang Su Cancer Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Jun Wang, Chief，Thoracic Surgery Service, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02696525    
Other Study ID Numbers: PTHO1601
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jun Wang, Peking University People's Hospital:
Circulating Tumor DNA
Lung cancer
lead time
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms