Cryobiopsy of Peripheral Lymph NodesCOLD SNAPNCT06120829
Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy
A study testing Cryobiopsy and Core Needle Biopsy in people with Cryobiopsy of Peripheral Lymph Nodes, run by San Antonio Uniformed Services Health Education Consortium at 1 site in United States.
Trial summary
Cryobiopsy of peripheral lymph nodes with suspected malignant potential with comparison to standard core needle biopsy. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cryobiopsy of Peripheral Lymph Nodes
- What is being tested?
- Cryobiopsy and Core Needle Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2023to Dec 2025
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Suspected or confirmed malignancy with suspected involvement of peripheral lymph nodes based on CT, PET-CT or ultrasound imaging with a clinical need for additional tissue or staging by tissue sampling
Who cannot join
- Age <18 or >89
- Patient preference
- Severe allergy to lidocaine precluding use
- Severe allergy to chlorhexidine precluding use
- Overlying Infection
- Active anticoagulation or anti-platelet therapy, with the exception of aspirin mono-therapy, that cannot be safely held as determined by the performing or prescribing physician.
- Major organs, vasculature or tissue that would preclude the safety of the procedure as determined by the performing physician.
- Inability to reach the lymph node through a core needle introducer sheath as determined by the performing physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Steven Stoffel, DO, 210-916-2153, steven.t.stoffel.mil@health.mil
Michal Sobieszczyk, MD
About this study
Cryobiopsy of peripheral lymph nodes with suspected malignant potential with comparison to standard core needle biopsy.
Read the detailed description
Peripheral lymph node biopsy has long been accomplished to establish malignant and non-malignant diagnoses of lymphadenopathy. For several decades patients have undergone fine needle aspiration (FNA) and core needle biopsy (CNB) with patient's proceeding to excisional biopsy if initial less invasive procedures are inadequate. The diagnostic yield of FNA followed by CNB has remained stagnant since the 1990's with a yield range of 66-93.6% depending on multiple factors such as patient factors and malignancy type. In one study they found that between 25-30% of patients undergoing FNA followed by CNB ultimately proceed to excisional biopsy which carries a higher rate of morbidity than FNA or CNB with complications including: Seroma 6.4%, Hematoma 3.2%, Dehiscence 1.8% and prolonged pain 1.4%, vs. CNB which has a less than 1% overall complication rate. In several malignancy types, but especially in lymphoproliferative disorders there is a gap in the ability to diagnose via CNB.
After the introduction of cryobiopsy for bronchoscopic lymph node biopsy there was a significant increase in yields with the most prominent increase seen among the lymphoproliferative disorders with an increase from 69% to 95%. Cryobiopsy samples had a significant increase in architecture which is critical in proper diagnosis of lymphoproliferative disorders and genetic sequencing. Bronchoscopic cryobiopsies of mediastinal lymph nodes did not demonstrate higher complication rates compared to fine needle aspiration despite the higher yields.
Thus far in the literature the use of cryobiopsy for the diagnosis of superficial peripheral lymph nodes of suspected malignant potential has not yet been described. The use of the ERBE 2 platform for tissue biopsy has been demonstrated to improve the diagnostic yield in some situations, such as mediastinal lymphadenopathy, without statistically significant increase in complications. This study seeks to evaluate the safety, feasibility, and effectiveness of the use of the 1.1mm cryoprobe of this platform to increase diagnostic yield of peripherally obtainable lymph nodes of malignant potential without the need for additional procedures such as excisional biopsy that carry a significantly increased risk compared to current initial biopsy methods such as FNA and CNB.
- Conditions
- Cryobiopsy of Peripheral Lymph Nodes
- Being tested
- Cryobiopsy, Core Needle Biopsy
- Keywords
- Cryobiopsy, Peripheral Lymphadenopathy, Lymphoma, Malignancy Staging
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryobiopsyProcedure or surgery
Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling
CryobiopsyDevice
Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling
Core Needle BiopsyProcedure or surgery
Core Needle Biopsy
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | FNA followed by Core Needle biopsy Receives: Procedure: Core Needle Biopsy |
| Experimental Arm | Experimental | FNA followed by cryobiopsy through a introducer sheath Receives: Procedure: Cryobiopsy; Device: Cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield by strict criteria
Measured: 7 days
Secondary outcomes (4)
Complication Rate
Measured: 30 days
Patient reported pain on Stanford Comparative Pain Scale
Measured: 5 days
Need for Repeat procedures
Measured: 30 days
Ability to proceed to next generation sequencing based on tissue obtained
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryobiopsy of Peripheral Lymph NodesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Antonio Uniformed Services Health Education Consortium
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Stephen Goertzen, San Antonio Uniformed Services Health Education Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120829
- Sponsor's protocol ID
- C.20231002
- Acronym
- COLD SNAP
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Following completion of analysis, the electronic medical record query will be destroyed and the Research Database will be de-identified by removing all remaining dates.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy
- ClinicalTrials.gov ID
- NCT06120829
- Acronym / sponsor ID
- COLD SNAP / C.20231002
- Conditions
- Cryobiopsy of Peripheral Lymph Nodes
- Keywords
- Cryobiopsy, Peripheral Lymphadenopathy, Lymphoma, Malignancy Staging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- San Antonio Uniformed Services Health Education ConsortiumUS federal agency
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (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.
Cryobiopsy of peripheral lymph nodes with suspected malignant potential with comparison to standard core needle biopsy.
Detailed description
Peripheral lymph node biopsy has long been accomplished to establish malignant and non-malignant diagnoses of lymphadenopathy. For several decades patients have undergone fine needle aspiration (FNA) and core needle biopsy (CNB) with patient's proceeding to excisional biopsy if initial less invasive procedures are inadequate. The diagnostic yield of FNA followed by CNB has remained stagnant since the 1990's with a yield range of 66-93.6% depending on multiple factors such as patient factors and malignancy type. In one study they found that between 25-30% of patients undergoing FNA followed by CNB ultimately proceed to excisional biopsy which carries a higher rate of morbidity than FNA or CNB with complications including: Seroma 6.4%, Hematoma 3.2%, Dehiscence 1.8% and prolonged pain 1.4%, vs. CNB which has a less than 1% overall complication rate. In several malignancy types, but especially in lymphoproliferative disorders there is a gap in the ability to diagnose via CNB.
After the introduction of cryobiopsy for bronchoscopic lymph node biopsy there was a significant increase in yields with the most prominent increase seen among the lymphoproliferative disorders with an increase from 69% to 95%. Cryobiopsy samples had a significant increase in architecture which is critical in proper diagnosis of lymphoproliferative disorders and genetic sequencing. Bronchoscopic cryobiopsies of mediastinal lymph nodes did not demonstrate higher complication rates compared to fine needle aspiration despite the higher yields.
Thus far in the literature the use of cryobiopsy for the diagnosis of superficial peripheral lymph nodes of suspected malignant potential has not yet been described. The use of the ERBE 2 platform for tissue biopsy has been demonstrated to improve the diagnostic yield in some situations, such as mediastinal lymphadenopathy, without statistically significant increase in complications. This study seeks to evaluate the safety, feasibility, and effectiveness of the use of the 1.1mm cryoprobe of this platform to increase diagnostic yield of peripherally obtainable lymph nodes of malignant potential without the need for additional procedures such as excisional biopsy that carry a significantly increased risk compared to current initial biopsy methods such as FNA and CNB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Procedure: Core Needle BiopsyFNA followed by Core Needle biopsy |
| Experimental Arm | Experimental | Procedure: Cryobiopsy, Device: CryobiopsyFNA followed by cryobiopsy through a introducer sheath |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-89
- Suspected or confirmed malignancy with suspected involvement of peripheral lymph nodes based on CT, PET-CT or ultrasound imaging with a clinical need for additional tissue or staging by tissue sampling
Key exclusion criteria (8 listed)
- Age <18 or >89
- Patient preference
- Severe allergy to lidocaine precluding use
- Severe allergy to chlorhexidine precluding use
- Overlying Infection
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 |
|---|---|---|
| CryobiopsyUse of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling | Procedure or surgery | Experimental Arm |
| CryobiopsyUse of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling | Device | Experimental Arm |
| Core Needle BiopsyCore Needle Biopsy | Procedure or surgery | Control Arm |
Primary outcome
Yield by strict criteria
Time frame: 7 days
4 secondary outcomes
Complication Rate
Time frame: 30 days
Patient reported pain on Stanford Comparative Pain Scale
Time frame: 5 days
Need for Repeat procedures
Time frame: 30 days
Ability to proceed to next generation sequencing based on tissue obtained
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No. Following completion of analysis, the electronic medical record query will be destroyed and the Research Database will be de-identified by removing all remaining dates.
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.
Brooke Army Medical Center
Fort Sam Houston, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryobiopsy and Core Needle Biopsy in people with Cryobiopsy of Peripheral Lymph Nodes, run by San Antonio Uniformed Services Health Education Consortium 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 8 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 7 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield by strict criteria (time frame: 7 days). 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 7 Nov 2023; AzTrials last refreshed its copy on 1 Nov 2026.