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

Lung Cancer Clinical Trial

Official title:

Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy and Their Clinical Implications.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03397355
• Other study ID #: Lung biopsy and biomarkers
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2019
• Source: China-Japan Friendship Hospital
• Contact: Jieping LEI, Ph.D.
• Phone: 010-84206408
• Email: jiepinglei[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

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