Autoantibodies in Breast Cancer Detection

NCT03623945 | Terminated

• 1 other identifier: SH ABCD
• Study Type: observational
• Target: 1,279
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

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

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

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

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

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

Interventions

Collection of blood OTHER

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 A; Cohort B; Cohort C; Cohort D; Cohort E

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanford Health: lead
• Inanovate: collaborator

Study Sites (2)

Sanford Health

Fargo, North Dakota, 58104, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Allison Watson, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 9, 2018
• Study Start: July 24, 2018
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: December 11, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)