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

NCT03397355 | Unknown DMC

• 1 other identifier: Lung biopsy and biomarkers
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Pulmonary Nodule; Lung Cancer; Biopsy; Biomarker.

Outcome Measures

Primary Outcomes (3)

• Death or survival

  Death or survival

  Baseline and every three- or six-month follow-up within two years for each patient.

• 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.

• 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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary nodules (single or multiple) by CT scans.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chen WANG, Ph.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieping LEI, Ph.D.

CONTACT

010-84206408; jiepinglei@126.com

Sinan WU, M.D.

CONTACT

010-84206408; tks0423@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2017
• First Posted: January 12, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CN (1)