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Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT02965391
Recruitment Status : Active, not recruiting
First Posted : November 16, 2016
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Chen KeZhong, Peking University People's Hospital

Brief Summary:
Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

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

Detailed Description:
For lung cancer patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Dynamic Changes and Surveillance of Circulating Tumor DNA in Surgical Non-small Cell Lung Cancer Patients
Study Start Date : November 2016
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Half-life of circulating tumor DNA after surgery [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. The variation of circulating tumor DNA level before and after surgery [ Time Frame: 3 months ]
  2. Correlation of circulating tumor DNA level after surgery with tumor recurrence [ Time Frame: 3 years ]
  3. Correlation of circulating tumor DNA level after surgery with clinical features [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
A series of lung cancer patients plasma before or 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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Histologically confirmed lung cancer patients who received completely tumor resection
Criteria

Inclusion Criteria:

  • Suspected lung cancer before surgery
  • No malignant tumor history within the past 5 years
  • The pulmonary nodule is not pure ground glass opacity
  • Patients must have given written informed consent

Exclusion Criteria:

  • Multiple primary lung cancer
  • R1,R2 resection
  • Histology confirmed not non-small cell lung cancer
  • Unqualified blood samples

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): NCT02965391


Locations
China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
National Natural Science Foundation of China
Investigators
Study Chair: Jun Wang, M.D. Peking University People's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chen KeZhong, Principal Investigator, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02965391     History of Changes
Other Study ID Numbers: PTHO1602
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chen KeZhong, Peking University People's Hospital:
Circulating Tumor DNA
Half time
Lung cancer
Surgery
Surveillance

Additional relevant 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