Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer

March 22, 2023 updated by: Gang Hou, China-Japan Friendship Hospital

The goal of this clinical trial is to evaluate raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer in visible lesions in the airway. The main question it aims to answer are: the diagnostic efficacy raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer.

The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who plan to undergo bronchoscopic biopsy or EBUS-TBNA
  • Visible intratracheal lesions under bronchoscope
  • Non-visible lesions suspected of lung cancer

Exclusion Criteria:

  • The patient could not tolerate further examination aimed at clarifying the cause of the disease or refused to accept further examination aimed at clarifying the cause of the disease due to poor general condition, serious organ dysfunction, etc
  • The patient has no definite diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Raman spectrum analysis
The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.
Diagnostic test: Raman spectrum
The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To establish the sensitivities and specificities of Raman spectroscopic analysis of bronchoscopic biopsy for lung cancer.
Time Frame: 7 days after the biopsy
The diagnosis would be confirmed according to the pathological results.
7 days after the biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 31, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-NHLHCRF-LX-01-0201-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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