Autoantibodies in Breast Cancer Detection

Breast Cancer Clinical Trial

— ABCD  

Official title:

Autoantibodies in Breast Cancer Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03623945
• Other study ID #: SH ABCD
• Status: Recruiting
• Start date: July 24, 2018
• Est. completion date: November 1, 2028

Study information

• Verified date: October 2023
• Source: Sanford Health
• Contact: Jenna Hove, RN BSN
• Phone: 605-312-3337
• Email: jenna.hove[@]sanfordhealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1550
• Est. completion date: November 1, 2028
• Est. primary completion date: November 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion Criteria:

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

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

Exclusion Criteria:

• 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:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Collection of blood
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

Locations

Country	Name	City	State
United States	Sanford Health	Fargo	North Dakota
United States	Sanford Health	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Sanford Health	Inanovate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years