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

• Conditions: Lung Cancer

• Registration Number: NCT03397355
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-30
• Study Start: 2018-01-01
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reasons of study termination	Baseline and every three- or six-month follow-up within two years for each patient.	Complete the study, Lost to follow-up, Withdrawal of informed consent, Terminated by the investigator, Severe adverse event(SAE).
Death or survival	Baseline and every three- or six-month follow-up within two years for each patient.	Death or survival
Disease progress	Baseline and every three- or six-month follow-up within two years for each patient.	Complete Response(CR), Partial Response(PR), Stable Disease(SD), Progressive Disease(PD)

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China