Carcinoma, Ductal, BreastCRYOSE01NCT02576106
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
A study testing Cryoablation in people with Carcinoma, Ductal, Breast and Menopausal, run by Centre Leon Berard at 1 site in France.
Trial summary
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication. The efficacy is defined by the rate of success of cryotherapy procedures. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Carcinoma, Ductal, Breast, Menopausal
- What is being tested?
- Cryoablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Jan 2020
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
- Menopausal women with age > 55 years
- Tumor size <= 15 mm by ultrasonography
- Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis \& Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
- Good lesion boundary with ultrasonography and MRI
- Minimal distance of 5 mm between the skin and the tumor
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- Performance Status 0-1
- Ability to understand and willingness to sign a written informed consent document
- Covered by a medical insurance
- Signed informed consent
Who cannot join
- Invasive lobular carcinoma
- Tumor with retro-nipple location
- Extended microcalcifications (> 15 mm) with mammography
- Xylocaine allergy
- Patient deprived of freedom
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.
The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.
On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.
- Conditions
- Carcinoma, Ductal, Breast, Menopausal
- Being tested
- Cryoablation
- Medical subject headings
- Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Also called Cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Cryoablation of the tumor followed by a lumpectomy as practiced in standard care Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of success of cryoablation procedure
percentage of viable cells in the piece of lumpectomy
Measured: 45 days after cryoablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Ductal, BreastStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Pilleul, MD-PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576106
- Sponsor's protocol ID
- ET15-001
- Acronym
- CRYOSE01
- Status last verified
- Aug 2018
- First submitted
- 12 Oct 2015
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
- ClinicalTrials.gov ID
- NCT02576106
- Acronym / sponsor ID
- CRYOSE01 / ET15-001
- Conditions
- Carcinoma, Ductal, Breast, Menopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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 primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.
The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.
On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Device: CryoablationCryoablation of the tumor followed by a lumpectomy as practiced in standard care |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
- Menopausal women with age > 55 years
- Tumor size <= 15 mm by ultrasonography
- Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis \& Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
- Good lesion boundary with ultrasonography and MRI
Key exclusion criteria (5 listed)
- Invasive lobular carcinoma
- Tumor with retro-nipple location
- Extended microcalcifications (> 15 mm) with mammography
- Xylocaine allergy
- Patient deprived of freedom
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 |
|---|---|---|
| CryoablationAlso: Cryotherapy | Device | Cryoablation |
Primary outcome
The rate of success of cryoablation procedure
Time frame: 45 days after cryoablation
percentage of viable cells in the piece of lumpectomy
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 22 Oct 2020.
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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.
Frank Pilleul, MD-PhD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Carcinoma, Ductal, Breast and Menopausal, run by Centre Leon Berard 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 10 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: finished, as of the sponsor's last update on 22 Oct 2020. 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?
The rate of success of cryoablation procedure (time frame: 45 days after cryoablation). 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 22 Oct 2020.