CompletedNot Applicable

Comparison of Endobronchial Ultrasound-Guided Biopsy Using Fine Needle Aspiration Versus Fine Needle Capillary Sampling

United States120 participantsStarted 2009-04

Plain-language summary

Primary objective: * To estimate the degree of agreement in diagnosis of cytologic samples from mediastinal lymph nodes obtained by Endobronchial Ultrasound (EBUS)-guided Fine Needle Capillary Sampling (FNC) versus Fine Needle Aspiration (FNA). Secondary objective: * To compare the quality of cytologic samples from mediastinal lymph nodes obtained by EBUS-guided FNC versus FNA. The quality of the samples will be assessed initially by MDACC on-site cytology technicians, and then corroborated by physicians in the department of cytology. This assessment will be performed utilizing the Mair's score 3. The score consists of a 0-10 scale: 1-2= poor; 3-6=good; 7-10=superior.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. patients 18 years or older
. Patients in which EBUS is indicated based on the suspicion of either benign or malignant disease in mediastinal and/or hilar lymph nodes. This will include patients who are in the hospital.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of times FNA and FNC agree on patient diagnosis (concordance)

Timeframe: 2 Years

Trial details

NCT IDNCT00886847

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

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