COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cryoablation.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Cancer of the Breast. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
Overview
This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.
Interventions
- Device Cryoablation
Takes place at single time point.
Primary outcome measures
- Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0 [Time frame: Through 3 year follow-up]
Secondary outcome measures (3)
- Proportion of patients who demonstrate progression-free survival (PFS) [Time frame: At 3 year follow-up]
- Proportion of patients who demonstrate disease-free survival (DFS) [Time frame: At 3 year follow-up]
- Proportion of patients who demonstrate overall survival (OS) [Time frame: At 3 year follow-up]
Eligibility criteria
Eligibility Criteria:
- Diagnosis of breast cancer.
- Mass must be visible on ultrasound and > 5 mm from skin.
- Not undergoing surgery, because:
- Patient has a medical condition that would not allow sedation or general anesthesia
- Surgery is not clinically indicated due to unresectable and/or metastatic disease
- Surgery is not clinically indicated for another reason
- Patient declines surgery
- At least 18 years old.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT05972343 · 202307067