Breast CancerCRIMCASNCT05825547
Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy
A study testing Cryotherapy treatment in people with Breast Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cryotherapy treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2022to 17 Jul 2024
- 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 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent
- The patient must be a member or beneficiary of a health insurance plan
- Patient with metastatic breast cancer with painful subcutaneous metastases.
- Patient eligible for cryotherapy.
- Therapeutic decision of antalgic and palliative treatment by cryotherapy taken in Pluridisciplinary Consultation Meeting.
- Patient available for 15-day follow-up.
Who cannot join
- The subject is in a period of exclusion determined by a previous study
- The subject us unable to express their consent or refuses to sign the consent form
- The patient is under safeguard of justice or state guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy: Descriptive Pilot Study.
Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. Studies describe complex responses with elevated levels of activating NK cells, circulating and anti-tumor T cells, and pro-inflammatory and NF-KB dependent cytokines.
In breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. Indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells The University Hospital of Nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with Argon. This technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. The aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy.
The study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. A better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.
- Conditions
- Breast Cancer
- Being tested
- Cryotherapy treatment
- Keywords
- cryotherapy, cytotoxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy treatmentProcedure or surgery
Cryotherapy treatment administered by an interventional radiologist: the cryotherapy needle is placed under local anesthesia, ultrasound monitoring in real time. A complete cryotherapy cycle is performed with: freezing until the entire tumor is frozen as judged by ultrasound, then thawing for the same duration and refreezing according to the same principle.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Not described Receives: Procedure: Cryotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Measured: Day 0
Description of the immunological makeup of the tumor after liquid nitrogen cryotherapy treatment
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Measured: Day 15
Secondary outcomes (9)
Patients' tolerance to cryotherapy treatment
Collection of complications and adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria
Measured: Day 15
Level of pain related to subcutaneous metastases before cryotherapy treatment
0-10 Visual analog scale. Higher scores mean worse outcome.
Measured: Day 0 immediately before cryotherapy treatment
Level of pain related to subcutaneous metastases after cryotherapy treatment
0-10 Visual analog scale. Higher scores mean worse outcome.
Measured: Day 0 immediately after cryotherapy treatment
Level of pain related to subcutaneous metastases after cryotherapy treatment
0-10 Visual analog scale. Higher scores mean worse outcome.
Measured: Day 15
Pain related to subcutaneous metastases before cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Measured: Day 0 immediately before cryotherapy treatment
Pain related to subcutaneous metastases after cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Measured: Day 0 immediately after cryotherapy treatment
Pain related to subcutaneous metastases after cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Measured: Day 15
Patient reported quality of before cryotherapy treatment
European Organisation for Research and Treatment of Cancer - C30 (EORTC QLQ-C30). This questionnaire is composed of 30 items grouped into 15 scales. A good quality of life is associated with a high score for the functional scales and a low score for the symptom scales
Measured: Day 0
Patient reported quality of after cryotherapy treatment
European Organisation for Research and Treatment of Cancer - C30 (EORTC QLQ-C30). This questionnaire is composed of 30 items grouped into 15 scales. A good quality of life is associated with a high score for the functional scales and a low score for the symptom scales
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start16 Feb 2022
- Primary completion8 Mar 2023
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Frandon, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825547
- Sponsor's protocol ID
- EMERGENCE GSO/2020/JF-001
- Acronym
- CRIMCAS
- Status last verified
- Feb 2025
- First submitted
- 11 Apr 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy: Descriptive Pilot Study.
- ClinicalTrials.gov ID
- NCT05825547
- Acronym / sponsor ID
- CRIMCAS / EMERGENCE GSO/2020/JF-001
- Conditions
- Breast Cancer
- Keywords
- cryotherapy, cytotoxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 24 Apr 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.
Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. Studies describe complex responses with elevated levels of activating NK cells, circulating and anti-tumor T cells, and pro-inflammatory and NF-KB dependent cytokines.
In breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. Indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells The University Hospital of Nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with Argon. This technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. The aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy.
The study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. A better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Procedure: Cryotherapy treatment |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must have given their free and informed consent
- The patient must be a member or beneficiary of a health insurance plan
- Patient with metastatic breast cancer with painful subcutaneous metastases.
- Patient eligible for cryotherapy.
- Therapeutic decision of antalgic and palliative treatment by cryotherapy taken in Pluridisciplinary Consultation Meeting.
Key exclusion criteria (3 listed)
- The subject is in a period of exclusion determined by a previous study
- The subject us unable to express their consent or refuses to sign the consent form
- The patient is under safeguard of justice or state guardianship
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 |
|---|---|---|
| Cryotherapy treatmentCryotherapy treatment administered by an interventional radiologist: the cryotherapy needle is placed under local anesthesia, ultrasound monitoring in real time. A complete cryotherapy cycle is performed with: freezing until the entire tumor is frozen as judged by ultrasound, then thawing for the same duration and refreezing according to the same principle. | Procedure or surgery | Cryotherapy |
Primary outcome
Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment
Time frame: Day 0
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Description of the immunological makeup of the tumor after liquid nitrogen cryotherapy treatment
Time frame: Day 15
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
9 secondary outcomes
Patients' tolerance to cryotherapy treatment
Time frame: Day 15
Level of pain related to subcutaneous metastases before cryotherapy treatment
Time frame: Day 0 immediately before cryotherapy treatment
Level of pain related to subcutaneous metastases after cryotherapy treatment
Time frame: Day 0 immediately after cryotherapy treatment
Level of pain related to subcutaneous metastases after cryotherapy treatment
Time frame: Day 15
Pain related to subcutaneous metastases before cryotherapy treatment
Time frame: Day 0 immediately before cryotherapy treatment
Pain related to subcutaneous metastases after cryotherapy treatment
Time frame: Day 0 immediately after cryotherapy treatment
Pain related to subcutaneous metastases after cryotherapy treatment
Time frame: Day 15
Patient reported quality of before cryotherapy treatment
Time frame: Day 0
Patient reported quality of after cryotherapy treatment
Time frame: Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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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.
Julien Frandon principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy treatment in people with Breast Cancer, run by Centre Hospitalier Universitaire de Nīmes 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 11 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment (time frame: Day 0). The study lists 2 primary outcomes in all. 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 11 Mar 2025.