Diagnostic Lab Test During Pleuroscopy for Lung Cancer

Recruiting at 3 trial locations

Overseen By Horiana Grosu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Known malignant pleural effusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

97 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. A type of laboratory testing called rapid on site evaluation of pleural touch preparations that uses pleural biopsy tissue samples collected during an already-scheduled pleuroscopy may be able to diagnose malignant pleural effusion.

Research Team

Horiana Grosu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients who are scheduled to undergo pleuroscopy with biopsy to check for cancerous fluid in the lung linings. It's not open to those already diagnosed with malignant pleural effusion or those who can't or won't consent.

Inclusion Criteria

I am scheduled for a pleuroscopy with biopsy.

Exclusion Criteria

Inability or unwillingness to give informed consent

I have fluid in my chest from cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pleuroscopy and Biopsy

Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after pleuroscopy and biopsy

Up to 1 year

Treatment Details

Interventions

• Biopsy
• Medical Chart Review
• Thoracoscopy

Trial Overview The study tests a lab technique called rapid on site evaluation of pleural touch preparations, using samples from biopsies taken during pleuroscopy, to diagnose malignant pleural effusion quickly.

Participant Groups

Group I: Observational (pleuroscopy, medical chart review) Experimental Treatment 3 Interventions

Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

Thoracoscopy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Approved in European Union as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema
• Thoracic sympathectomy

Approved in Canada as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Approved in Japan as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+