search
Back to results

Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy (CRIMCAS)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cryotherapy treatment
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring cryotherapy, cytotoxicity

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • CHU de NimesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryotherapy

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Patients' tolerance to cryotherapy treatment
Scoring of complications and adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria
Level of pain related to subcutaneous metastases before cryotherapy treatment
0-10 Visual analog scale
Level of pain related to subcutaneous metastases after cryotherapy treatment
0-10 Visual analog scale
Level of pain related to subcutaneous metastases after cryotherapy treatment
0-10 Visual analog scale
Pain related to subcutaneous metastases before cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120
Pain related to subcutaneous metastases after cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120
Pain related to subcutaneous metastases after cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120
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
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

Full Information

First Posted
April 11, 2023
Last Updated
April 11, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
search

1. Study Identification

Unique Protocol Identification Number
NCT05825547
Brief Title
Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy
Acronym
CRIMCAS
Official Title
Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy: Descriptive Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
cryotherapy, cytotoxicity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment
Description
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Time Frame
Day 0
Title
Description of the immunological makeup of the tumor after liquid nitrogen cryotherapy treatment
Description
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Patients' tolerance to cryotherapy treatment
Description
Scoring of complications and adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria
Time Frame
Day 15
Title
Level of pain related to subcutaneous metastases before cryotherapy treatment
Description
0-10 Visual analog scale
Time Frame
Day 0 immediately before cryotherapy treatment
Title
Level of pain related to subcutaneous metastases after cryotherapy treatment
Description
0-10 Visual analog scale
Time Frame
Day 0 immediately after cryotherapy treatment
Title
Level of pain related to subcutaneous metastases after cryotherapy treatment
Description
0-10 Visual analog scale
Time Frame
Day 15
Title
Pain related to subcutaneous metastases before cryotherapy treatment
Description
Brief Pain Inventory (BPI): score from 0-120
Time Frame
Day 0 immediately before cryotherapy treatment
Title
Pain related to subcutaneous metastases after cryotherapy treatment
Description
Brief Pain Inventory (BPI): score from 0-120
Time Frame
Day 0 immediately after cryotherapy treatment
Title
Pain related to subcutaneous metastases after cryotherapy treatment
Description
Brief Pain Inventory (BPI): score from 0-120
Time Frame
Day 15
Title
Patient reported quality of before cryotherapy treatment
Description
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
Time Frame
Day 0
Title
Patient reported quality of after cryotherapy treatment
Description
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
Time Frame
Day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Frandon
Phone
04.66.68.67.22
Email
julien.frandon@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Frandon
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nimes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.34.00
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Julien Frandon
First Name & Middle Initial & Last Name & Degree
Jean-Paul Beregi
First Name & Middle Initial & Last Name & Degree
Nadine Houede
First Name & Middle Initial & Last Name & Degree
Frédéric Fiteni

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy

We'll reach out to this number within 24 hrs