Breast Cancer, Preneoplastic Conditions, BRCAPhase 3NCT02539615
A Trial of the ForeCYTE Breast Aspirator for Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years Old
A Phase 3 study testing ForeCYTE Breast Aspirator in people with Breast Cancer, Preneoplastic Conditions, BRCA, run by Atossa Therapeutics, Inc. at 2 sites in Israel.
Trial summary
The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology. Including collecting, processing and shipping samples, training staff, processing samples, sample interpretation and accurate and timely… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Preneoplastic Conditions, BRCA
- What is being tested?
- ForeCYTE Breast Aspirator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2015to Mar 2016
- Phase
- Phase 3
- 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, female, age 30-55 years, from whom bi-lateral specimens can be obtained.
- The following additional considerations apply:
- Women with prior mastectomy/lumpectomy may be considered for NAF-collection in the contralateral (non-operated) breast only if they were:
- Stage I or Stage II at the time of surgery;
- Have completed any and all hormonal therapy, chemotherapy, or targeted therapy at least one year prior to inclusion;
- Are considered disease-free (NED- No Evidence of Disease) at the time of study entry;
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- Women under the age 30 may be enrolled if they are within 10 years of the age at diagnosis of breast cancer in a first-degree relative. No subject under the age of 21 may be enrolled.
- Any woman for whom NAF-cytology testing is considered to be beneficial by her physician. This includes, but is not limited to women with first- and/or second degree relatives with breast- or ovarian cancer. Known presence of a BRCA-1 or BRCA-2 germline mutation is allowed but not required. If known, any such mutation will be noted on the Case Report Form. The protocol does not provide for testing of women without known germ-line mutations.
- Non-lactating and non-pregnant.
- Good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.
- Willing to give informed consent and follow study procedures as directed.
Who cannot join
- Medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the Principal Investigator.
- Pregnancy or suspicion of pregnancy.
- Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.
- No or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.
- Participation in an investigational drug or device study less than 30 days prior to enrollment in this study.
- Pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study.
- Acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
The BARUCH PADEH Medical Center
Poria – Neve Oved, Lower Galilee, 15208
Ziv Medical Center
Safed, Upper Galilee, 13100
About this study
Official title: A Single-arm, Multi-center Trial of the ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years of Age
The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology. Including collecting, processing and shipping samples, training staff, processing samples, sample interpretation and accurate and timely reporting in a manner resembling routine clinical use. The study will include a subset of patients who are known carriers of a BRCA germline mutation. NAF from this subset will be submitted for molecular testing in addition to cytology.
- Being tested
- ForeCYTE Breast Aspirator
- Medical subject headings
- Breast Neoplasms, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForeCYTE Breast AspiratorDevice
| Study group | Role | What they receive |
|---|---|---|
| ForeCYTE Breast Aspirator - Nipple Aspirate Fluid Collection | Experimental | Nipple Aspirate is collected using the ForeCYTE Breast Aspirator Receives: Device: ForeCYTE Breast Aspirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAF cytological classification(s), according to the modified King Classification.
Measured: 1 day (single time point)
Secondary outcomes (3)
The IBIS (Tyrer-Cuzick) risk score (10-year and lifetime breast cancer risk estimate.
Measured: 1 day (single time point)
Safety, as reported by adverse events experienced after NAF collection with ForeCYTE Breast Aspirator
Measured: 1 day (single time point)
micro-RNA (subgroup analysis of BRCA mutation carriers only)
development of micro-RNA panel that signals the transition to breast cancer
Measured: 1 day (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, Preneoplastic Conditions, BRCAStudies 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 3
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atossa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jelle Kylstra, Study director, Atossa Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539615
- Sponsor's protocol ID
- GCP005
- Status last verified
- Jan 2016
- First submitted
- 1 Sep 2015
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multi-center Trial of the ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years of Age
- ClinicalTrials.gov ID
- NCT02539615
- Acronym / sponsor ID
- GCP005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Atossa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 3 Sep 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 purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology. Including collecting, processing and shipping samples, training staff, processing samples, sample interpretation and accurate and timely reporting in a manner resembling routine clinical use. The study will include a subset of patients who are known carriers of a BRCA germline mutation. NAF from this subset will be submitted for molecular testing in addition to cytology.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ForeCYTE Breast Aspirator - Nipple Aspirate Fluid Collection | Experimental | Device: ForeCYTE Breast AspiratorNipple Aspirate is collected using the ForeCYTE Breast Aspirator |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy, female, age 30-55 years, from whom bi-lateral specimens can be obtained.
- Any woman for whom NAF-cytology testing is considered to be beneficial by her physician. This includes, but is not limited to women with first- and/or second degree relatives with breast- or ovarian cancer. Known presence of a BRCA-1 or BRCA-2 germline mutation is allowed but not required. If known, any such mutation will be noted on the Case Report Form. The protocol does not provide for testing of women without known germ-line mutations.
- Non-lactating and non-pregnant.
- Good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.
- Willing to give informed consent and follow study procedures as directed.
Key exclusion criteria (7 listed)
- Medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the Principal Investigator.
- Pregnancy or suspicion of pregnancy.
- Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.
- No or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.
- Participation in an investigational drug or device study less than 30 days prior to enrollment in this study.
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 |
|---|---|---|
| ForeCYTE Breast Aspirator | Device | ForeCYTE Breast Aspirator - Nipple Aspirate Fluid Collection |
Primary outcome
NAF cytological classification(s), according to the modified King Classification.
Time frame: 1 day (single time point)
3 secondary outcomes
The IBIS (Tyrer-Cuzick) risk score (10-year and lifetime breast cancer risk estimate.
Time frame: 1 day (single time point)
Safety, as reported by adverse events experienced after NAF collection with ForeCYTE Breast Aspirator
Time frame: 1 day (single time point)
micro-RNA (subgroup analysis of BRCA mutation carriers only)
Time frame: 1 day (single time point)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
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.
Jelle Kylstra study director
Atossa Therapeutics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ForeCYTE Breast Aspirator in people with Breast Cancer, Preneoplastic Conditions, BRCA, run by Atossa Therapeutics, Inc. at 2 sites in Israel.
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 11 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: withdrawn, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
NAF cytological classification(s), according to the modified King Classification. (time frame: 1 day (single time point)). 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 25 Jan 2016.