Lymphoma Clinical Trial
Official title:
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
A prospective diagnostic clinical study randomising patients undergoing endobronchial
ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and
hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy
forceps (EBUS-TBNB).
The study aims to establish whether the use of EBUS-TBNB can significantly increase the
diagnostic yield over EBUS-TBNA, without an increase in complication rates.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Scheduled for EBUS-TBNA as part of clinical care - Lymph nodes larger than 10mm in diameter - Age > 18 years - Able to provide written informed consent Exclusion Criteria: - Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) - Inability to obtain informed consent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Germany | Thoraxklinik, University of Heidelberg | Heidelberg | |
United Kingdom | Chelsea and Westminster Hospital | London | |
United Kingdom | The Royal Brompton Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Royal Brompton & Harefield NHS Foundation Trust | Chelsea and Westminster NHS Foundation Trust, Heidelberg University |
Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms. | The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below: Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour. Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas. Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium. |
18 months | No |
Secondary | The difference in the complication rate between the two study arms | 24 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
Active, not recruiting |
NCT04270266 -
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT01949883 -
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
|
Phase 1 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
Completed |
NCT04434937 -
Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
|
Phase 2 | |
Completed |
NCT01855750 -
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
|
Phase 3 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT00775268 -
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03936465 -
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
|
Phase 1 |