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

A Prospective Study of Advanced NSCLC Patients Genomic Landscape Through Sputum NGS Detection

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.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Diagnostic test: Next generation sequencing

Detailed Description

With the advancements in the development of targeted therapy, the detection of actionable genes has become routine practice in diagnosing lung cancer, especially in non-small cell lung cancer (NSCLC). Due to its non-invasiveness and great accessibility, plasma-based mutation profiling, with a sensitivity of approximately 70% relative to tissue samples, is widely used in clinical settings. Profiling using other body fluids such as pleural effusion, ascites, cerebrospinal fluid have been actively explored. Circulating cell-free DNA has also been shown to be present in other bodily fluids such as sputum and urine, which have potential to serve as liquid biopsy media for comprehensive mutation profiling. In this study, we investigated the potential of sputum obtained from NSCLC patients for mutation profiling using matched tissue, plasma and sputum from more than 30 advanced-stage NSCLC patients.

Baseline tissues, plasma and sputum samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (tissue 1000X, sputum 1000X, plasma cfDNA 10000X), in different methods will be compared.

Primary endpoints:

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

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Zhou Chengzhi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sputum group; Sputum samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (sputum 1000X)	Diagnostic test: Next generation sequencing; Extract DNA from sputum sample, minimum DNA amount should be over 50ng.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare different sample types with concordence rate, sensitivity, and specificity.	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;; 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.; 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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Principal Investigator: Chengzhi Zhou, Dr. PhD., The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): April 20, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CROC2004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No