Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study

Peking University

Status: Unknown

Conditions: Lung Neoplasms; Carcinoma; Non-small-cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02907606

PKUPH-XW1401

Details and patient eligibility

About

This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.

Full description

Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.

Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.

This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 to 80 years
• Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection
• Completed and explicit information about TNM staging
• Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.
• Patients must have given written informed consent

Exclusion criteria

• Unable to comply with the study procedure
• Malignant tumor history within the past 5 years
• Coexisting small cell lung cancer
• Unqualified tissue, blood or urine samples