NCT05799027

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

March 8, 2023

Last Update Submit

March 22, 2023

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • To establish the sensitivities and specificities of Raman spectroscopic analysis of bronchoscopic biopsy for lung cancer.

    The diagnosis would be confirmed according to the pathological results.

    7 days after the biopsy

Study Arms (1)

Raman spectrum analysis

EXPERIMENTAL

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

Diagnostic Test: Raman spectrum

Interventions

Raman spectrumDIAGNOSTIC_TEST

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

Raman spectrum analysis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Mingming Deng, MD

CONTACT

86 18801336854isdeng1017@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 5, 2023

Study Start

March 31, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 5, 2023

Record last verified: 2023-03