Breast Cancer - Ductal Carcinoma in Situ (DCIS)SHIELDNCT05946759
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
A study testing Histolog Scanner in people with Breast Cancer - Ductal Carcinoma in Situ (DCIS) and Breast-Conserving Surgery, run by SamanTree Medical SA at 1 site in Germany.
Trial summary
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast-Conserving Surgery
- What is being tested?
- Histolog Scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2023to 12 Mar 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female Subject ≥18 years old.
- Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma.
- Subject is able to read, understand and sign the informed consent.
Who cannot join
- Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery.
- Subject with previous radiotherapy of the ipsilateral breast.
- Subject with multicentric/multilateral breast cancer.
- Subject with planned mastectomy, tumor-adapted breast reduction.
- Subject with pre-surgical/ preoperative neo-adjuvant treatment.
- Subject is pregnant/ lactating.
- Participation in any other clinical study that would affect data acquisition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
- Being tested
- Histolog Scanner
- Keywords
- Reoperation Rate, Breast Conserving Surgery, Confocal laser scanning microscope, Confocal microscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histolog ScannerDevice
The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Active comparator | 50 prospective subjects Receives: Device: Histolog Scanner |
| Historical | No intervention | 40 historical subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation Rate
Differences in the rate of reoperation due to cancer positive margins
Measured: 2-30 days post Breast Surgery
Secondary outcomes (4)
Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance]
To observe real life clinical performance of the HLS and accessories when used intraoperatively
Measured: 0-30 days post Breast Surgery
System Usability Scale (SUS) of the IVD device and accessories [Usability]
To survey usability of the HLS and accessories when used intraoperatively
Measured: Only during the time of the breast surgery
Change in hospital cost with or without IVD device and accessories [Economic Impact]
To evaluate the economic impact for the hospital/payer of the reoperation rate
Measured: 30 days post surgery date
Incidence of adverse device effects [Safety]
Incidence of adverse device effects during surgery
Measured: Only during the time of the breast surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start10 Oct 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer - Ductal Carcinoma in Situ (DCIS)Studies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- SamanTree Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Vincenz Krankenhaus GmbH, Paderborn
- Responsible party
- Sponsor
- Investigators
- Michael P Lux, Prof. Dr MBA, Principal investigator, St. Vincenz Krankenhaus GmbH, Paderborn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946759
- Sponsor's protocol ID
- SHIELD
- Acronym
- SHIELD
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)
- ClinicalTrials.gov ID
- NCT05946759
- Acronym / sponsor ID
- SHIELD / SHIELD
- Keywords
- Reoperation Rate, Breast Conserving Surgery, Confocal laser scanning microscope, Confocal microscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- SamanTree Medical SAIndustry (pharma, biotech, devices)
- Collaborators
- St. Vincenz Krankenhaus GmbH, Paderborn
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 14 Jul 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.
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | Active comparator | Device: Histolog Scanner50 prospective subjects |
| Historical | No intervention | –40 historical subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult female Subject ≥18 years old.
- Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma.
- Subject is able to read, understand and sign the informed consent.
Key exclusion criteria (7 listed)
- Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery.
- Subject with previous radiotherapy of the ipsilateral breast.
- Subject with multicentric/multilateral breast cancer.
- Subject with planned mastectomy, tumor-adapted breast reduction.
- Subject with pre-surgical/ preoperative neo-adjuvant treatment.
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 |
|---|---|---|
| Histolog ScannerThe PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment. | Device | Prospective |
Primary outcome
Reoperation Rate
Time frame: 2-30 days post Breast Surgery
Differences in the rate of reoperation due to cancer positive margins
4 secondary outcomes
Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance]
Time frame: 0-30 days post Breast Surgery
System Usability Scale (SUS) of the IVD device and accessories [Usability]
Time frame: Only during the time of the breast surgery
Change in hospital cost with or without IVD device and accessories [Economic Impact]
Time frame: 30 days post surgery date
Incidence of adverse device effects [Safety]
Time frame: Only during the time of the breast surgery
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 21 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Michael P Lux, Prof. Dr MBA principal investigator
St. Vincenz Krankenhaus GmbH, Paderborn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histolog Scanner in people with Breast Cancer - Ductal Carcinoma in Situ (DCIS) and Breast-Conserving Surgery, run by SamanTree Medical SA at 1 site in Germany.
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 3 inclusion and 7 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 21 Mar 2024. 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 Germany. 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?
Reoperation Rate (time frame: 2-30 days post Breast Surgery). 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 21 Mar 2024.