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Autoantibodies in Breast Cancer Detection (ABCD)

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ClinicalTrials.gov Identifier: NCT03623945
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Inanovate
Information provided by (Responsible Party):
Sanford Health

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

Condition or disease Intervention/treatment
Breast Cancer Other: Collection of blood

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1550 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Autoantibodies in Breast Cancer Detection
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.
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).
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.
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients only
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623945


Contacts
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Contact: Jenna Hove, RN BSN 605-312-3337 jenna.hove@sanfordhealth.org

Locations
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United States, North Dakota
Sanford Health Not yet recruiting
Fargo, North Dakota, United States, 58104
Contact: Jennifer Rasmussen, RN    701-234-7258    jennifer.f.rasmussen@sanfordhealth.org   
Principal Investigator: Kristi Egland, PhD         
United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Laurie Auch    605-312-3325    laurie.auch@sanfordhealth.org   
Principal Investigator: Kristi Egland, PhD         
Sponsors and Collaborators
Sanford Health
Inanovate
Investigators
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Study Chair: Kristi Egland, PhD Sanford Health

Additional Information:

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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT03623945     History of Changes
Other Study ID Numbers: SH ABCD
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs