Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05799027

Collaborator

(none)

200

Enrollment

Arm

21.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Diagnostic Test: Raman spectrum	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer

Anticipated Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

To establish the sensitivities and specificities of Raman spectroscopic analysis of bronchoscopic biopsy for lung cancer. [7 days after the biopsy]
The diagnosis would be confirmed according to the pathological results.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gang Hou, Principal Investigator, China-Japan Friendship Hospital

ClinicalTrials.gov Identifier:

NCT05799027

Other Study ID Numbers:

2022-NHLHCRF-LX-01-0201-05

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Apr 5, 2023