Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

Lung Neoplasms Clinical Trial

Official title:

Dynamic Changes and Surveillance of Circulating Tumor DNA in Surgical Non-small Cell Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965391
• Other study ID #: PTHO1602
• Status: Completed
• Start date: November 2016
• Est. completion date: November 2019

Study information

• Verified date: March 2020
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Half-life of circulating tumor DNA after surgery		3 months
Secondary	The variation of circulating tumor DNA level before and after surgery		3 months
Secondary	Correlation of circulating tumor DNA level after surgery with tumor recurrence		3 years
Secondary	Correlation of circulating tumor DNA level after surgery with clinical features		3 months