LymphomaEnDolNCT05075655
Endobronchial Diagnosis of Lymphoma
A study testing Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration in people with Lymphoma, run by University Hospital, Caen at 1 site in France.
Trial summary
The present study aimed to assess the diagnostic performance of ultrasound-guided endobronchial intra-nodal miniforceps biopsy (EBUS-MFB) in the diagnosis of "de novo" mediastinal lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2021to Sep 2023
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CaenUH
Caen, Normandy, 14000
Dutheil M Jean-Jacques, 0231065351 ext. +33, dutheil-jj@chu-caen.fr
About this study
Official title: Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.
The present study aimed to assess the diagnostic performance of ultrasound-guided endobronchial intra-nodal miniforceps biopsy (EBUS-MFB) in the diagnosis of "de novo" mediastinal lymphoma.
Read the 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
- Conditions
- Lymphoma
- Being tested
- Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration
- Keywords
- ebus, endobronchial ultrasound-guided, EBUS-MFB, intra-nodal miniforceps biopsy, EBUS-transbronchial forceps biopsy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspirationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-MFB and EBUS-TBNA | Experimental | patient will have both TBNA and MFB in the same operating time Receives: Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
positivity of the procedure in Diagnosis and Subtyping of lymphoma
a sample wil be considered positive if it allows the clinical management of the patient, without additional sampling required.
Measured: up to 3 years
Secondary outcomes (1)
every adverse effect related to the procedure
infectious process related to the procedure, hemoptysis over 50cc, worsening of respiratory status requiring hospitalization
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start20 Apr 2021
- Primary completion20 Apr 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075655
- Sponsor's protocol ID
- 20-028
- Acronym
- EnDol
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.
- ClinicalTrials.gov ID
- NCT05075655
- Acronym / sponsor ID
- EnDol / 20-028
- Conditions
- Lymphoma
- Keywords
- ebus, endobronchial ultrasound-guided, EBUS-MFB, intra-nodal miniforceps biopsy, EBUS-transbronchial forceps biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 13 Oct 2021 (actual)
- 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.
The present study aimed to assess the diagnostic performance of ultrasound-guided endobronchial intra-nodal miniforceps biopsy (EBUS-MFB) in the diagnosis of "de novo" mediastinal lymphoma.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS-MFB and EBUS-TBNA | Experimental | Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspirationpatient will have both TBNA and MFB in the same operating time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspirationMediastinal 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. | Device | EBUS-MFB and EBUS-TBNA |
Primary outcome
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.
1 secondary outcome
every adverse effect related to the procedure
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration in people with Lymphoma, run by University Hospital, Caen at 1 site in France.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain M Magnier, MD (0291069029 ext. +33, magnier-r@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positivity of the procedure in Diagnosis and Subtyping of lymphoma (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2021.