Autoantibodies in Breast Cancer Detection (ABCD)

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Collection of blood

• Study Type: Observational
• Enrollment (Estimated): 1550

Contacts and Locations

• Study Contact: Name: Jenna Hove, RN BSN; Phone Number: 605-312-3337; Email: jenna.hove@sanfordhealth.org

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Not yet recruiting
      • Sanford Health
      • Contact: Jennifer Rasmussen, RN; Phone Number: 701-234-7258; Email: jennifer.f.rasmussen@sanfordhealth.org
      • Principal Investigator: Kristi Egland, PhD
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Recruiting
      • Sanford Health
      • Principal Investigator: Kristi Egland, PhD
      • Contact: Laurie Auch; Phone Number: 605-312-3325; Email: laurie.auch@sanfordhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
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.	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
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	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
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.	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanford Health
• Collaborators: Inanovate
• Investigators: Study Chair: Kristi Egland, PhD, Sanford Health

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SH ABCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No