Anatomic Stage IA Breast Cancer AJCC v8NCT03715959
Nipple Aspirate Fluid in Detecting Breast Cancer
A study testing Aspiration of Breast and Biospecimen Collection in people with Anatomic Stage IA Breast Cancer AJCC v8 and Anatomic Stage IB Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- What is being tested?
- Aspiration of Breast and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 1 Jan 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BREAST CANCER: Must be > 1 year from pregnancy, lactation.
- BREAST CANCER: Must be currently diagnosed with known breast cancer in breast.
- BREAST CANCER: Must not be currently diagnosed with cancers other than breast cancer.
- BREAST CANCER: Must not have been gone through surgery, radiotherapy or chemotherapy within 30 days of enrollment.
- HEALTHY SUBJECTS: No history of breast cancer and must not be currently diagnosed with any other cancer.
- HEALTHY SUBJECTS: Must be > 1 year from pregnancy, lactation.
- HEALTHY SUBJECTS: Must be willing to have a clinical breast exam and/or mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the James Cancer Hospital within the past 90 days prior to their NAF procedure. The clinical breast exam result and/or mammograms must be read as not suspicious for breast cancer.
- HEALTHY SUBJECTS: Must be willing to keep the clinic informed of their breast health status for 1 year.
Who cannot join
- Subjects who are currently pregnant, lactating, or within a year of pregnancy/lactation. Pregnancy testing will not be required of any patients over 60 years of age, or any patient who has undergone bilateral oophorectomy.
- Subjects who currently are diagnosed with cancers other than breast cancer.
- Subjects who cannot give an informed consent.
- Male gender of any age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid
This trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations.
Read the detailed description
PRIMARY OBJECTIVES:
- To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least 40-years-old.
II. To analyze the samples using a novel protein nanopore-based detection platform to evaluate the efficacy of the platform for breast cancer diagnosis through detection of biomarkers.
OUTLINE:
Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
After completion of study, participants are followed up at 1 year.
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- Aspiration of Breast, Biospecimen Collection
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration of BreastProcedure or surgery
Undergo NAF
Biospecimen CollectionProcedure or surgery
Undergo NAF
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (nipple aspiration fluid) | Experimental | Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts. Receives: Procedure: Aspiration of Breast; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers expression levels
Nipple aspiration fluid samples will be compared between breast cancer participants and healthy participants. will perform the logistic regression model for each biomarker that shows any difference between the breast cancer patients and healthy individuals. Then we will include multiple biomarkers in one model while controlling for confounders.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start10 Dec 2020
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IA Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Carson, Ohio State University Comprehensive Cancer Center
- Investigators
- William Carson, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715959
- Sponsor's protocol ID
- OSU-16288
- Other IDs
- NCI-2018-01437
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2018
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid
- ClinicalTrials.gov ID
- NCT03715959
- Acronym / sponsor ID
- OSU-16288
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 23 Oct 2018 (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 trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations.
Detailed description
PRIMARY OBJECTIVES:
- To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least 40-years-old.
II. To analyze the samples using a novel protein nanopore-based detection platform to evaluate the efficacy of the platform for breast cancer diagnosis through detection of biomarkers.
OUTLINE:
Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
After completion of study, participants are followed up at 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (nipple aspiration fluid) | Experimental | Procedure: Aspiration of Breast, Procedure: Biospecimen CollectionParticipants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BREAST CANCER: Must be > 1 year from pregnancy, lactation.
- BREAST CANCER: Must be currently diagnosed with known breast cancer in breast.
- BREAST CANCER: Must not be currently diagnosed with cancers other than breast cancer.
- BREAST CANCER: Must not have been gone through surgery, radiotherapy or chemotherapy within 30 days of enrollment.
- HEALTHY SUBJECTS: No history of breast cancer and must not be currently diagnosed with any other cancer.
Key exclusion criteria (4 listed)
- Subjects who are currently pregnant, lactating, or within a year of pregnancy/lactation. Pregnancy testing will not be required of any patients over 60 years of age, or any patient who has undergone bilateral oophorectomy.
- Subjects who currently are diagnosed with cancers other than breast cancer.
- Subjects who cannot give an informed consent.
- Male gender of any age.
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 |
|---|---|---|
| Aspiration of BreastUndergo NAF | Procedure or surgery | Diagnostic (nipple aspiration fluid) |
| Biospecimen CollectionUndergo NAF | Procedure or surgery | Diagnostic (nipple aspiration fluid) |
Primary outcome
Biomarkers expression levels
Time frame: Up to 1 year
Nipple aspiration fluid samples will be compared between breast cancer participants and healthy participants. will perform the logistic regression model for each biomarker that shows any difference between the breast cancer patients and healthy individuals. Then we will include multiple biomarkers in one model while controlling for confounders.
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 25 Feb 2025.
- The JameslineLink provided by the sponsor.
- 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.
William Carson, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration of Breast and Biospecimen Collection in people with Anatomic Stage IA Breast Cancer AJCC v8 and Anatomic Stage IB Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 8 inclusion and 4 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 25 Feb 2025. 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 United States. 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?
Biomarkers expression levels (time frame: Up to 1 year). 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 Feb 2025.