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OctavaPink for Women With Dense Breast After Negative Mammography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02209389
Recruitment Status : Unknown
Verified August 2014 by Eventus Diagnostics Ltd.
Recruitment status was:  Not yet recruiting
First Posted : August 5, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Eventus Diagnostics Ltd

Study Description
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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 assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3 or 4). The device is intended to increase breast cancer detection in the described patient population. Based upon the result of OctavaPink, the patient will be further evaluated by their physician.

Condition or disease Intervention/treatment
Breast Cancer Device: MRI

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 for women with dense breast tissue, and will not affect the treatment of the participants. Part 1A is an internal part done by EventusDx and no statistical evaluation is needed.

Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70% sensitivity.

Part 1B will assess the properties of the OctavaPink test using cases and controls obtained via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control status before using the test to affect clinical management of patients.

Objectives:

(i) To obtain a sensitivity estimate ≥60% with 95% CI lower limit ≥50% in the whole group of cancer cases (DCIS, IDC and ILC); also to obtain a sensitivity estimate with the same properties in the subset of cases with invasive cancer (IDC and ILC).

(ii) To obtain a specificity estimate ≥90% in controls with 95% CI lower limit ≥85%.

Part 2 will examine the yield of cancer detection by MRI/biopsy among women who have a positive OctavaPink test result in the dense breast negative mammography population.

Objectives:

(i) To compare the yield of cancer detection via MRI/biopsy among women with a positive OctavaPink test versus a negative OctavaPink test result.

(ii) To estimate the proportion of patients who are positive for the test in the target population

Part 3 will assess sensitivity of OctavaPink test in an enriched population of women with dense breasts and negative mammography.

Objectives: To obtain an estimate of sensitivity in women with dense breast tissue and negative mammography that is broadly consistent with that found in the dense breast population (but not necessarily negative mammogram) in Parts 1A and 1B.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1750 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: OctavaPink® For Dense Breast After Negative Mammography
Study Start Date : August 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Groups and Cohorts
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Group/Cohort Intervention/treatment
Positive OctavaPink
Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI).
 Device: MRI
For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results).
Other Name: Magnetic Resonance Imaging
Negative OctavaPink - control

For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and recalled for an MRI and any additional testing (required by the MRI).

MRI won't be performed to all negative OctavaPink results. Only one negative control will be assigned to each OctavaPink positive result.

 Device: MRI
For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results).
Other Name: Magnetic Resonance Imaging


Outcome Measures
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Primary Outcome Measures :
  1. Positive MRI as an approval for a positive OctavaPink test [ Time Frame: Approximately two month following a positive Octava test ]

Biospecimen Retention:   Samples With DNA
Human plasma samples

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population for all parts of the protocol includes women above 30, who have had a mammography in the past 5-18 months, for which the result was negative (BIRADS assessment category 1 or 2), and on which they were defined as having dense breast tissue (BIRADS composition/density 3 or 4).
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Contacts and Locations
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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): NCT02209389


Contacts
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Contact: Galit Yahalom, PhD. +97226738854 galit@eventusdx.com
Contact: Sarah Cohen, CRA +97226738854 sarah@eventusdx.com

Locations
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United States, Michigan
Detroit Clinical Research Center
Detroit, Michigan, United States, 48201
Contact: Benjamin Taggart, B.S.    248-716-7009    benjamin.taggart@dcrc.us   
United States, Texas
MD Anderson cancer center
Houston, Texas, United States, 77030
Principal Investigator: Bevers, Prof.         
Israel
Shaarey Tzedek
Jerusalem, Israel
Contact: Strano, Prof.       strano@szmc.org.il   
Principal Investigator: Strano, Prof.         
Shiba
Ramat Gan, Israel
Contact: Sklair, Dr.       Miri.SklairLevy@sheba.health.gov.il   
Principal Investigator: Sklair, Dr.         
Kaplan medical center
Rehovot, Israel
Contact: Tanir Allweis, Dr.       tanirallweis@gmail.com   
Principal Investigator: Tanir Allweis, Dr.         
Sourasky medical center
Tel Aviv, Israel
Contact: Orit Golan, Dr.       oritgolan@gmail.com   
Principal Investigator: Orit Golan, Dr.         
Italy
Fondazione Carlo ferri
Rome, Italy
Contact: Iacobelli, Dr.       daniela.iacobelli@alice.it   
Principal Investigator: Iacobelli, Dr.         
Sponsors and Collaborators
Eventus Diagnostics Ltd
Investigators
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Principal Investigator: Edith Perez, Prof. Mayo Clinic, Jacksonville Florida USA
More Information
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Additional Information:

Publications:

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Responsible Party: Eventus Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT02209389    
Other Study ID Numbers: OctavaPink for Dense Breast
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by Eventus Diagnostics Ltd:
breast cancer
cancer associated auto antibodies
breast cancer blood test
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases