LymphadenopathyNCT00886847
Comparison of Endobronchial Ultrasound-Guided Biopsy Using Fine Needle Aspiration Versus Fine Needle Capillary Sampling
A study testing Lymph Node Needle Tissue Collections in people with Lymphadenopathy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphadenopathy
- What is being tested?
- Lymph Node Needle Tissue Collections
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. patients under 18 years or younger
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specimen Adequacy and Diagnostic Agreement of Fine Needle Aspiration (FNA) VS. Fine Needle Capillary Sampling (FNC) of Endobronchial Ultrasound-Guided Biopsy of Mediastinal Lymph Nodes
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.
Read the detailed description
Tissue Sample Collection:
If you agree to take part in this study, you will have your already scheduled endobronchial ultrasound-guided biopsy performed after you have been given a drug to make you sleep. You will be asked to sign a separate informed consent for the biopsy procedure.
During a standard of care biopsy procedure, there are normally 3-5 tissue sample collections performed. For the purposes of this study, you will have a total of 4 tissue collections performed during the biopsy procedure. Two tissue collections (2) using the FNC method, and 2 tissue collections using the FNA method.
If the first 4 tissue sample collections do not provide good enough tissue samples to perform the diagnosis, additional sample collections may be performed. If more samples are collected, these samples will not be used for the purposes of this study and will only be collected for diagnostic purposes.The sampling will be done by the pulmonologist who is performing your procedure.
The first 4 tissue samples that are collected for the purposes of this study will be examined to determine the quality of the sample as well as for diagnostic purposes.
Medical Record Information:
Information from your medical record will be collected 1 time for this study. The information collected will include information about your diagnosis, the number of radiation treatments you may have had, and additional information about your medical history. The information will be de-identified and stored in a research database on a password protected computer that only the study doctor and study staff will have access to.
Length of Study:
You will remain on study for the duration of biopsy procedure. After the biopsy has been performed, and your medical record information has been collected you will no longer be on study.
This is an investigational study. The endobronchial ultrasound-guided biopsy of the lymph nodes is FDA approved. Both methods of tissue collection (FNA and FNC) are FDA approved for the purposes of this study.
Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lymphadenopathy
- Being tested
- Lymph Node Needle Tissue Collections
- Keywords
- Lung, Lymphadenopathy, Enlarged hilar or/and mediastinal lymph adenopathy, Benign, Malignant, Mediastinal lymph nodes, Hilar lymph nodes, Fine Needle Aspiration, FNA, Fine Needle Capillary Sampling, FNC, Endobronchial Ultrasound-Guided Biopsy, EBUS, Tissue Sample, Suction
- Medical subject headings
- Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph Node Needle Tissue CollectionsProcedure or surgery
Also called Fine Needle Aspiration, Fine Needle Capillary
Total of two lymph nodes sampled per patient. Four biopsies will be taken from each lymph node. Two with suction (FNA) and two without suction (FNC).
| Study group | Role | What they receive |
|---|---|---|
| EBUS FNA vs FNC | Experimental | Not described Receives: Procedure: Lymph Node Needle Tissue Collections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of times FNA and FNC agree on patient diagnosis (concordance)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphadenopathyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodolfo C. Morice, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886847
- Sponsor's protocol ID
- 2009-0051
- Status last verified
- Aug 2012
- First submitted
- 21 Apr 2009
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Casal RF, Staerkel GA, Ost D, Almeida FA, Uzbeck MH, Eapen GA, Jimenez CA, Nogueras-Gonzalez GM, Sarkiss M, Morice RC. Randomized clinical trial of endobronchial ultrasound needle biopsy with and without aspiration. Chest. 2012 Sep;142(3):568-573. doi: 10.1378/chest.11-0692.
PubMed 22156610
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Adequacy and Diagnostic Agreement of Fine Needle Aspiration (FNA) VS. Fine Needle Capillary Sampling (FNC) of Endobronchial Ultrasound-Guided Biopsy of Mediastinal Lymph Nodes
- ClinicalTrials.gov ID
- NCT00886847
- Acronym / sponsor ID
- 2009-0051
- Conditions
- Lymphadenopathy
- Keywords
- Lung, Lymphadenopathy, Enlarged hilar or/and mediastinal lymph adenopathy, Benign, Malignant, Mediastinal lymph nodes, Hilar lymph nodes, Fine Needle Aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tissue Sample Collection:
If you agree to take part in this study, you will have your already scheduled endobronchial ultrasound-guided biopsy performed after you have been given a drug to make you sleep. You will be asked to sign a separate informed consent for the biopsy procedure.
During a standard of care biopsy procedure, there are normally 3-5 tissue sample collections performed. For the purposes of this study, you will have a total of 4 tissue collections performed during the biopsy procedure. Two tissue collections (2) using the FNC method, and 2 tissue collections using the FNA method.
If the first 4 tissue sample collections do not provide good enough tissue samples to perform the diagnosis, additional sample collections may be performed. If more samples are collected, these samples will not be used for the purposes of this study and will only be collected for diagnostic purposes.The sampling will be done by the pulmonologist who is performing your procedure.
The first 4 tissue samples that are collected for the purposes of this study will be examined to determine the quality of the sample as well as for diagnostic purposes.
Medical Record Information:
Information from your medical record will be collected 1 time for this study. The information collected will include information about your diagnosis, the number of radiation treatments you may have had, and additional information about your medical history. The information will be de-identified and stored in a research database on a password protected computer that only the study doctor and study staff will have access to.
Length of Study:
You will remain on study for the duration of biopsy procedure. After the biopsy has been performed, and your medical record information has been collected you will no longer be on study.
This is an investigational study. The endobronchial ultrasound-guided biopsy of the lymph nodes is FDA approved. Both methods of tissue collection (FNA and FNC) are FDA approved for the purposes of this study.
Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS FNA vs FNC | Experimental | Procedure: Lymph Node Needle Tissue Collections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. patients under 18 years or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymph Node Needle Tissue CollectionsAlso: Fine Needle Aspiration, Fine Needle CapillaryTotal of two lymph nodes sampled per patient. Four biopsies will be taken from each lymph node. Two with suction (FNA) and two without suction (FNC). | Procedure or surgery | EBUS FNA vs FNC |
Primary outcome
Number of times FNA and FNC agree on patient diagnosis (concordance)
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Derived from this study: PubMed 22156610Casal RF, Staerkel GA, Ost D, Almeida FA, Uzbeck MH, Eapen GA, Jimenez CA, Nogueras-Gonzalez GM, Sarkiss M, Morice RC. Randomized clinical trial of endobronchial ultrasound needle biopsy with and without aspiration. Chest. 2012 Sep;142(3):568-573. doi: 10.1378/chest.11-0692.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolfo C. Morice, MD study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymph Node Needle Tissue Collections in people with Lymphadenopathy, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of times FNA and FNC agree on patient diagnosis (concordance) (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.