Lymphadenopathy Clinical Trial
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Completed |
NCT02948907 -
"Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
|
N/A | |
| Completed |
NCT01770405 -
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
|
N/A | |
| Completed |
NCT01769248 -
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
|
N/A | |
| Enrolling by invitation |
NCT01465425 -
Extracolonic Findings on Computed Tomography (CT) Colonography
|
||
| Active, not recruiting |
NCT04928560 -
Diagnosis of Superficial Lymphadenopathy
|
||
| Recruiting |
NCT02916459 -
EBUS-TBNA vs Flex 19G EBUS-TBNA
|
N/A | |
| Terminated |
NCT01720745 -
Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA
|
||
| Completed |
NCT03226964 -
Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy
|
N/A | |
| Active, not recruiting |
NCT02506933 -
Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant
|
Phase 2 | |
| Recruiting |
NCT02789371 -
Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions
|
N/A | |
| Completed |
NCT02592837 -
EBUS-TBNA vs Flex 19G EBUS-TBNA
|
N/A | |
| Completed |
NCT04743583 -
Prevalence and Malignant Involvement of Calcified Intrathoracic Lymph Nodes in Patients Undergoing Endosonography
|
||
| Active, not recruiting |
NCT03499808 -
S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis
|
Phase 2 | |
| Active, not recruiting |
NCT01563133 -
Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
|
N/A | |
| Completed |
NCT01526486 -
Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer
|
N/A | |
| Completed |
NCT01130402 -
A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy
|
N/A | |
| Terminated |
NCT02872831 -
Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle
|
N/A | |
| Recruiting |
NCT02497079 -
Diagnostic Accuracy of Polymerase Chain Reaction for Mycobacterium Tuberculosis Using EBUS-TBNA Samples
|
N/A | |
| Completed |
NCT01384357 -
Ultrasound-Guided Needle Biopsy in the Diagnosis of Malignant Cervical Lymphadenopathies
|
N/A |