- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05075655
Endobronchial Diagnosis of Lymphoma (EnDol)
Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Every patients will be sampled using both EBUS-MFB and the standard of care EBUS-TBNA (transbronchial needle aspiration).
It is a monocentric investigation. Pathologist will not know the way of sampling while analysing the samples
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Romain M Magnier, MD
- Phone Number: +33 0291069029
- Email: magnier-r@chu-caen.fr
Study Contact Backup
- Name: Pierre M Cuchet, MD
- Phone Number: +33 0231063029
- Email: cuchet-p@chu-caen.fr
Study Locations
-
-
Normandy
-
Caen, Normandy, France, 14000
- Recruiting
- CaenUH
-
Contact:
- Dutheil M Jean-Jacques
- Phone Number: +33 0231065351
- Email: dutheil-jj@chu-caen.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathological mediastinal nodes within reach of EBUS sampling on CT-scan.
- Lymphoma suspicion by a senior clinical hematologist
- Affiliated to the french public health care insurance
Exclusion Criteria:
- Peripherical pathological lymph nodes reachable without general anesthesia
- Antithrombotic medication that cannot be stopped le time of the procedure.
- Unstable respiratory status
- History of lymphoma
- Latex or xylocaine allergia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EBUS-MFB and EBUS-TBNA
patient will have both TBNA and MFB in the same operating time
|
Mediastinal node is sampled using three path of classic ultrasound guided transbronchial needle aspiration (EBUS-TBNA). A reduce size forceps is then inserted inside the mediastinal node via the duc EBUS-TBNA made and biopsies (EBUS-MFB) are made using real time ultrasound guidance. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
positivity of the procedure in Diagnosis and Subtyping of lymphoma
Time Frame: up to 3 years
|
a sample wil be considered positive if it allows the clinical management of the patient, without additional sampling required.
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
every adverse effect related to the procedure
Time Frame: up to 3 years
|
infectious process related to the procedure, hemoptysis over 50cc, worsening of respiratory status requiring hospitalization
|
up to 3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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