Clinical trial NCT03623945: Autoantibodies in Breast Cancer Detection
Official title: Autoantibodies in Breast Cancer Detection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Sanford Health
Sponsor class: OTHER
Collaborators: name: Inanovate
First posted: 2018-08-09
Enrollment: 1279
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Autoantibodies for breast cancer diagnosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Allison Watson, MD
role: PRINCIPAL_INVESTIGATOR
References: