Monitoring the Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy.

China-Japan Friendship Hospital

Status: Unknown

Conditions: Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03397355

Lung biopsy and biomarkers

Details and patient eligibility

About

In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. However, most of previous data were based on late stage tumor patients. This study plans to utilize the minimally invasive method to detect the changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs, autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed as suspected lung cancer patients with pulmonary nodules (single or multiple) by CT scans, and the maximum diameter of nodule is between 8mm and 3cm;
• Male or female, with age of 18~80 years;
• Agree to take the pulmonary nodule biopsy, and sign the Informed Consent.

Exclusion criteria

• With severe comorbidities and unable to participate in this study;
• Diagnosed with acute respiratory tract infection, for instance fungus, mycobacterium tuberculosis or other bacteria, virus, etc., one month prior to the study recruitment;
• Pregnant or maternal women;
• Diagnosed with other carcinoma, and the pulmonary nodules suspected of stemming from other sites;
• Unable for regular follow-ups according to the research protocol;
• Blood sample is not qualified for biomarker testing.