Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients

Lung Neoplasms Clinical Trial

Official title:

A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Stage ⅢA Non-small-cell Lung Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02696525
• Other study ID #: PTHO1601
• Status: Not yet recruiting
• Start date: December 2018
• Est. completion date: December 2021

Study information

• Verified date: May 2018
• Source: Peking University People's Hospital
• Contact: Kezhong Chen, M.D.
• Phone: (+86)13488752289
• Email: mdkzchen[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 145
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 80 years

• Undergo radical surgery(R0 resection)

• Histologically confirmed diagnosis of stage ?A 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

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
China	Guang Dong General Hospital, Thoracic Surgery	Guangzhou	Guangdong
China	Jiang Su Cancer Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	San Valley Biotechnology Incorporated

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches		4 years
Secondary	Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers		4 years
Secondary	The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample		1 year
Secondary	Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis		4 years
Secondary	Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis		4 years
Secondary	CtDNA predictive value between locoregional recurrence and distant metastasis		4 years