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Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification

6. juni 2014 opdateret af: Provista Diagnostics, Inc

Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept

The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins in your blood samples. The biomarker results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.

Studieoversigt

Status

Ukendt

Betingelser

Brystkræft

Detaljeret beskrivelse

As part of the study, 35 mL or 2 1/2 tablespoons of blood will be drawn from your arm at each study visit.

This study has 2 visits. Visit 1 will take about 1 hour. Visit 2 is a follow up visit at 6 months taking about 1 hour.

Visit 1- Screening and Blood Collection:

The following procedures will be done at the clinical research facility:

The study doctor and/or study staff will explain the study and all the study procedures.
You will be asked to review, sign and date this informed consent before any procedures are done.
The study doctor and/or study staff will ask you questions about your health status and medical history and record this information.
35 mL or 2 ½ tablespoons of blood will be collected from your arm.
The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.

Visit 2 - Follow up:

If you have been diagnosed with cancer between visit 1 and visit 2, you will not be required to complete visit 2. If you have been diagnosed with LCIS or DCIS, you will be requested to return for visit 2. Otherwise you will return to the center for visit 2.

The following procedures will be performed:

You will have a follow-up breast evaluation performed. Your follow-up breast evaluation may occur prior to Visit 2 if you have it performed at a different facility or it may be performed during this study visit.
The study doctor and/or study staff will assess your health and medical history.
35 mL or 2 1/2 tablespoons of blood will be collected from your arm.
The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.

Your blood sample will be sent to the study Sponsor, Provista Diagnostics, Inc. for testing.

The test results will not be reported back to the study doctor and will not be used to determine or change your treatment. This testing will be done in addition to any routine testing that your study doctor performs. You will not receive the results of these tests.

Up to 350 subjects will take part in this study. Patients will be enrolled at one of seven sites.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

350

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85006
    - Banner Health
- California
  - Sacramento, California, Forenede Stater, 95816
    - Sutter Institute
  - San Diego, California, Forenede Stater, 92103
    - Scripps
  - Santa Barbara, California, Forenede Stater, 93102-1200
    - Sansum Clinic
- Massachusetts
  - Peabody, Massachusetts, Forenede Stater, 01960
    - Lahey Clinic
- Michigan
  - Detroit, Michigan, Forenede Stater, 48202
    - Henry Ford Hospital
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02903
    - Rhode Island Hospital
- South Dakota
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Avera Research Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 49 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Primary Care Clinics

Beskrivelse

Inclusion Criteria:

Adult women from 25 years of age to below 50 years of age
Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
Study visit and blood collection within 3 weeks (21 days) of ACR BI-RADS assessment
Patient agrees to return for diagnostic follow-up and blood collection at 6 months unless a positive cancer diagnosis is made between study visits 1 and 2. Individuals diagnosed with LCIS and DCIS will agree to return for visit 2
Samples collected under IRB approval and Informed Consent
Testing performed under IRB approval or waiver (as applicable)

Exclusion Criteria:

Adults from 50 years of age or older and below 25 years of age
Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
Subjects that have had a breast biopsy performed at any time prior to the study visit
Samples not collected under IRB approval and Informed Consent
Testing not performed under IRB approval or waiver (as applicable)
Prior breast cancer diagnosis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
Breast Cancer ACR BI-RAD Category 3 or 4 result

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Training Tidsramme: Baseline	Part I: Establish an acceptable algorithm for generation of a single numerical score from the combination of the 5 cancer biomarkers that comprise the dtectDX-Breast Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman.	Baseline
Blinded Validation Tidsramme: 6 months	Demonstrate proof-of-concept for use of the dtectDx-Breast Assay to assess likelihood of breast cancer malignancy in conjunction with the physicians clinical and radiological evaluations.	6 months

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Clinical Sensitivity/Specificity Tidsramme: Baseline	Demonstrate the numerical score, collaborated via proprietary algorithm (greater then 60 is an elevated score, less then 60 is a normal score), for the dtectDx-Breast Assay increases the likelihood of malignant breast cancer detection when used adjunctively with the assessment of BI-RADS Categories 3 and 4 compared to the assessment of BI-RADS Categories 3 and 4 alone.	Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Provista Diagnostics, Inc

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Related Info

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2013

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Forventet)

1. august 2014

Datoer for studieregistrering

Først indsendt

5. april 2013

Først indsendt, der opfyldte QC-kriterier

19. april 2013

Først opslået (Skøn)

24. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2014

Sidst verificeret