Whether Sputum Can Serve as an Alternative Source for Liquid Biopsy in Patients With Lung Cancer

NCT05034445 | Completed DMC

• 1 other identifier: CROC2004
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in sputum, tissues and blood samples of patients with advanced NSCLC. In order to explore the use of sputum as a diagnosis method for NSCLC patients, we will collect relevant clinical information and follow-up treatment information. The primary endpoint will reveal the effectiveness, accuracy, and feasibility in sputum, as compared to tissues and blood samples. This study aims to study the feasibility and advantages/disadvantages of using sputum as an noval body fluid biopsy option.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Compare different sample types with concordence rate, sensitivity, and specificity.

  1. Concordance rate was defined as the fraction of the total number of true positive and true negative patients relative to the cohort or indicated subgroup; 2. Sensitivity rate means true positive rate, true positive patients were defined as those who carried at least one genomic alteration that were detected in both matched samples. 3. Specificity rate means ture negative rate, patients were as defined true negative if no alteration was detected from either matched sample.

  up to 2 years

Study Arms (3)

Sputum group

Sputum samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (sputum 1000X)

Diagnostic Test: Next generation sequencing

Tissue group

Clinical data review to obtain corresponding tissue samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (tissue 1000X)

Plasma group

Clinical data review to obtain corresponding plasma samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (plasma 10000X)

Interventions

Next generation sequencing DIAGNOSTIC_TEST

Extract DNA from sputum sample, minimum DNA amount should be over 50ng.

Sputum group

Eligibility Criteria

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

Study Population

Planning to enroll more than 30 newly diagnosed advanced NSCLC patients, age over 18 years old following the eligibility criteria.

You may qualify if:

• Patients with stage IIIB-IV NSCLC in AJCC TNM stage (8th edition) confirmed with histology or cytology;
• Newly diagnosed;
• There are sufficient samples that meet the requirements for examination;
• Eligible for the next anti-tumor systemic treatment;
• Willing to sign the consent inform, age ≥18 years;
• Patients willing to cooperate with the planned follow-up schedule;
• Permit to collect clinical data needed by the institute.

You may not qualify if:

• Diagnosed with other malignant tumors at the same time (except for fully treated cervical carcinoma in situ, basal or squamous cell skin cancer);
• The patient has other serious diseases that may affect follow-up and short-term survival;
• Any other medical conditions and social/psychological problems that investigator evaluated is not suitable to enroll in this study;
• Absents of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computer tomography (CT) during clinical follow-up.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Zhou Chengzhi

Guangzhou, Guangdong, 510120, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor DNA obtained from patients' tissue biopsy, plasma or sputum.

Study Officials

• Chengzhi Zhou, Dr. PhD.

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: September 5, 2021
• Study Start: January 30, 2020
• Primary Completion: April 20, 2021
• Study Completion: April 28, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

CN (1)