Breast CancerABCDNCT03623945
Autoantibodies in Breast Cancer Detection
An observational study of Breast Cancer, run by Sanford Health at 2 sites in United States.
Trial summary
Prospective, single-center study in women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. We are no longer enrolling women who had normal Screening mammograms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Collection of blood
- Type of treatment
- Injection or infusion
- How many people
- 1,279 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jul 2018to 11 Mar 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. The study team will enroll approximately 1,550 participants at Sanford Health in Sioux Falls, SD and Fargo, ND. Cohort A= 300 participants, Cohort B= 250 participants, Cohort C= 500 participants and Cohort D= 500 participants.
Who may be able to join
- All Cohorts:
- Women age 18 and older
- Understand and provide informed consent and HIPAA Authorization prior to initiation of any study-specific procedures
- Cohort A:
- Recent abnormal mammogram followed by a breast biopsy
- Initial diagnosis of Stage I, II, III or IV invasive breast cancer
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- Cohort B:
- Recent abnormal mammogram followed by a breast biopsy
- Diagnosed benign breast tumor with high-risk pathology. This would include, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), flat epithelia atypia and phylloides
- Cohort C:
- Recent abnormal mammogram followed by a breast biopsy
- Diagnosed benign breast tumor. This would include, but is not limited to, fibroadenoma, papilloma, fibrocystic changes, and Pseudoangiomatous stromal hyperplasia (PASH)
- Cohort D:
- Normal screening mammogram within the last 6 months
Who cannot join
- All Cohorts:
- Men.
- Unable or unwilling to give written informed consent
- Cohort A:
- History of cancer other than non-melanoma basal or squamous cell skin carcinoma, ductal carcinoma in situ (DCIS) and cervical carcinoma in situ.
- Cohort B:
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- History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
- Cohort C:
- History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
- Cohort D:
- History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
- History of or current autoimmune disease including but not limited to Sjogrens Syndrome, Systemic Sclerosis (SSc), Scleroderma (Scl) and Dermatomyositis, Systemic Lupus Erythematosus, Multiple Sclerosis, Type I Diabetes, Rheumatoid Arthritis
- History of abnormal mammogram
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sanford Health
Fargo, North Dakota, 58104
Sanford Health
Sioux Falls, South Dakota, 57104
About this study
Prospective, single-center study in women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. We are no longer enrolling women who had normal Screening mammograms.
- Conditions
- Breast Cancer
- Being tested
- Collection of blood
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of bloodOther
Collection of blood only to look at circulating autoantibodies that recognize breast cancer proteins to potentially be used as a biosensor for identifying patients with increased risk of having breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients who have recently had an abnormal mammogram, followed by a breast biopsy and an initial diagnosis of Stage I, II, III or IV invasive breast cancer, will be invited to participate. Stage I, II and III participants will be further categorized into high-risk and low-risk. For the purposes of this study, participants with at least one of the following will be considered high-risk; any triple negative cancer, any grade III cancer, lymph node involvement, tumor greater than 2cm, or any patient receiving cytotoxic chemotherapy. Receives: Other: Collection of blood | |
| Cohort B | Patients who have recently had an abnormal mammogram, followed by a breast biopsy and diagnosed with a benign but high-risk pathology, will be invited to participate. This includes, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), flat epithelia atypia or phylloides.
Accrual to Cohort B is complete. Receives: Other: Collection of blood | |
| Cohort C | Patients who have recently had an abnormal mammogram, followed by a breast biopsy and diagnosed with a benign tumor, will be invited to participate. This includes, but is not limited to, fibroadenoma, papilloma, fibrocystic changes and Pseudoangiomatous stromal hyperplasia (PASH). Accrual to Cohort C is complete Receives: Other: Collection of blood | |
| Cohort D | Patients who have had a normal screening mammogram within the last 6 months will be invited to participate. Accrual to Cohort D is complete. Receives: Other: Collection of blood | |
| Cohort E | Patients who have recently had an abnormal mammogram, followed by a breast biopsy and an initial diagnosis of Stage I, II, III invasive breast cancer.
Patients who have recently had an abnormal mammogram, followed by a breast biopsy, and diagnosed with a benign but high-risk pathology.
Cohort E has 3 sub-groups. For the purposes of this study, participants with a breast cancer will be categorized as E1-malignant high risk, of E2-malignant low risk.
Patients who have recently had an abnormal mammogram, followed by a breast biopsy, and diagnosed with a benign but high-risk pathology, will be invited to participate.
These patients will be considered E3-benign high-risk. Receives: Other: Collection of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autoantibodies for breast cancer diagnosis
The data from Phase I will be tested and validated with newly diagnosed BCa patient samples from Cohort A, and age-matched healthy controls taken from Cohort D, and a risk score will be developed based on a composite of autoantibodies for breast cancer diagnosis. A Cox Proportional Hazards (PH) Regression will be used to analyze a case-cohort study design to validate the risk score by identifying breast cancer cases from those cases in Cohorts B, C and D.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start24 Jul 2018
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Why it stopped: Study closed to enrollment and data and specimen collection due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,279 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Collaborators
- Inanovate
- Responsible party
- Sponsor
- Investigators
- Allison Watson, MD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623945
- Sponsor's protocol ID
- SH ABCD
- Acronym
- ABCD
- Status last verified
- Oct 2023
- First submitted
- 26 Jul 2018
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoantibodies in Breast Cancer Detection
- ClinicalTrials.gov ID
- NCT03623945
- Acronym / sponsor ID
- ABCD / SH ABCD
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study closed to enrollment and data and specimen collection due to lack of funding.
- Enrolment
- 1,279 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Collaborators
- Inanovate
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 9 Aug 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.
Prospective, single-center study in women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. We are no longer enrolling women who had normal Screening mammograms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Collection of bloodPatients who have recently had an abnormal mammogram, followed by a breast biopsy and an initial diagnosis of Stage I, II, III or IV invasive breast cancer, will be invited to participate. Stage I, II and III participants will be further categorized into high-risk and low-risk. For the purposes of this study, participants with at least one of the following will be considered high-risk; any triple negative cancer, any grade III cancer, lymph node involvement, tumor greater than 2cm, or any patient receiving cytotoxic chemotherapy. |
| Cohort B | – | Other: Collection of bloodPatients who have recently had an abnormal mammogram, followed by a breast biopsy and diagnosed with a benign but high-risk pathology, will be invited to participate. This includes, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), flat epithelia atypia or phylloides. Accrual to Cohort B is complete. |
| Cohort C | – | Other: Collection of bloodPatients who have recently had an abnormal mammogram, followed by a breast biopsy and diagnosed with a benign tumor, will be invited to participate. This includes, but is not limited to, fibroadenoma, papilloma, fibrocystic changes and Pseudoangiomatous stromal hyperplasia (PASH). Accrual to Cohort C is complete |
| Cohort D | – | Other: Collection of bloodPatients who have had a normal screening mammogram within the last 6 months will be invited to participate. Accrual to Cohort D is complete. |
| Cohort E | – | Other: Collection of bloodPatients who have recently had an abnormal mammogram, followed by a breast biopsy and an initial diagnosis of Stage I, II, III invasive breast cancer. Patients who have recently had an abnormal mammogram, followed by a breast biopsy, and diagnosed with a benign but high-risk pathology. Cohort E has 3 sub-groups. For the purposes of this study, participants with a breast cancer will be categorized as E1-malignant high risk, of E2-malignant low risk. Patients who have recently had an abnormal mammogram, followed by a breast biopsy, and diagnosed with a benign but high-risk pathology, will be invited to participate. These patients will be considered E3-benign high-risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. The study team will enroll approximately 1,550 participants at Sanford Health in Sioux Falls, SD and Fargo, ND. Cohort A= 300 participants, Cohort B= 250 participants, Cohort C= 500 participants and Cohort D= 500 participants.
Key inclusion criteria (14 listed)
- Women age 18 and older
- Understand and provide informed consent and HIPAA Authorization prior to initiation of any study-specific procedures
- Recent abnormal mammogram followed by a breast biopsy
- Initial diagnosis of Stage I, II, III or IV invasive breast cancer
- Recent abnormal mammogram followed by a breast biopsy
Key exclusion criteria (13 listed)
- All Cohorts:
- History of cancer other than non-melanoma basal or squamous cell skin carcinoma, ductal carcinoma in situ (DCIS) and cervical carcinoma in situ.
- History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
- History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
- History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ.
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 |
|---|---|---|
| Collection of bloodCollection of blood only to look at circulating autoantibodies that recognize breast cancer proteins to potentially be used as a biosensor for identifying patients with increased risk of having breast cancer | Other | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Autoantibodies for breast cancer diagnosis
Time frame: 5 years
The data from Phase I will be tested and validated with newly diagnosed BCa patient samples from Cohort A, and age-matched healthy controls taken from Cohort D, and a risk score will be developed based on a composite of autoantibodies for breast cancer diagnosis. A Cox Proportional Hazards (PH) Regression will be used to analyze a case-cohort study design to validate the risk score by identifying breast cancer cases from those cases in Cohorts B, C and D.
Results and safety
The study was stopped early (reason given: Study closed to enrollment and data and specimen collection due to lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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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.
Allison Watson, MD principal investigator
Sanford Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sanford Health at 2 sites 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 14 inclusion and 13 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: stopped early, as of the sponsor's last update on 11 Dec 2024. 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 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 was stopped early (reason given: Study closed to enrollment and data and specimen collection due to lack of funding.). Results are not available in the source record.
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?
Autoantibodies for breast cancer diagnosis (time frame: 5 years). 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 11 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.