Status:
UNKNOWN
OctavaPink for Women With Dense Breast After Negative Mammography
Lead Sponsor:
Eventus Diagnostics Ltd
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-79 years
Brief Summary
The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS asses...
Detailed Description
This is a multicenter, prospective study containing 3 parts: Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as follows: Part 1A will optimize the OctavaPink test...
Eligibility Criteria
Inclusion
- Subjects with dense breast tissue according to ACR criteria, (BIRADS composition/density 3 or 4), or with specific area of high density behind the nipple.
- Subject with current mammography BIRADS assessment category other than 3.
- Signed inform consent form.
- Additional inclusion criteria for Part 1A and Part 1B cases and Part 3 cases
- • Subjects with current biopsy/surgery proven breast cancer.
- Additional inclusion criteria for Part 1A controls, Part 1B controls • Subjects with current negative mammography (BIRADS assessment category 1 or 2).
- Additional inclusion criteria for Part 2
- • Subjects with current negative mammography (BIRADS assessment category 1 or 2). All will perform an additional 1 year (12-18 months) up mammography to verify negative results.
- Additional inclusion criteria for Part 3 • Enriched patient population - Subjects with current/recent (less than 12 months) negative mammography (BIRADS assessment category 1 or 2). Mammography evaluation can be performed after recruiting.
Exclusion
- Previous or concurrent malignancies of any type except for basal cell carcinoma of the skin, squamous-cell carcinoma of the skin or cervical carcinoma in situ.
- Previous or current ADH, ALH, LCIS.
- Autoimmune disorders diagnosed subjects.
- Hematological malignancies.
- Subjects under active chemotherapy treatment or chemotherapy in the past 6 months.
- Steroid treatment in the past 3 months.
- Subject undergoing immunosuppressive treatments.
- Subject with current mammography BIRADS assessment category of 3.
- Pregnancy at time of recruitment.
- Doctor medical judgment that prohibits participation in the study.
- Participating in a parallel clinical study that involves drug treatment, or may influence the course of this clinical trial.
- Additional exclusion criteria for Part 3
- • Subjects with current mammography BIRADS assessment other than 1 or 2.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2017
Estimated Enrollment :
1750 Patients enrolled
Trial Details
Trial ID
NCT02209389
Start Date
August 1 2014
End Date
August 1 2017
Last Update
August 19 2014
Active Locations (7)
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1
Detroit Clinical Research Center
Detroit, Michigan, United States, 48201
2
MD Anderson cancer center
Houston, Texas, United States, 77030
3
Shaarey Tzedek
Jerusalem, Israel
4
Shiba
Ramat Gan, Israel