Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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.

At each visit, 35mL or 2 1/2 tablespoons of blood will be drawn from your arm.

Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification

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

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.

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.

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.

Provista Diagnostics, Inc

Clarisa Gracia, MD, MSCE

Women of reproductive age who will undergo cancer treatment may participate in a study to surgically remove ovarian tissue and store it, frozen, for their potential use in the future. 20% of collected tissue will be used for research.

Chemotherapy and radiation therapy for cancer can compromise the ability to become pregnant. Experiments in animals and humans have tried to collect, freeze and store eggs to see if they can be saved for possible later use. While studies are promising, it is still uncertain whether such approaches will ultimately prove to be useful in practice for achieving pregnancy in humans. The main purpose of this study is to see whether it is possible to remove and store ovarian tissues by freezing. It is hoped that, in the future, frozen, stored ovarian tissue can be used to achieve pregnancy. Before receiving chemotherapy or radiation therapy, subjects will have a piece of the ovaries, or one of two ovaries, removed by surgery. The tissues will be frozen by a special method in an effort to prevent the eggs from being damaged. The majority (80%) of the tissue will be stored for potential use in case the patient is unable to achieve pregnancy in the future, and part of the tissue (20%) will be used for studying how the eggs can be grown in the laboratory.

Ovarian Freezing Before Cancer Treatment

Ovarian Tissue Freezing Prior to Chemotherapy or Radiation Therapy: a Study by the Oncofertility Consortium

Several factors, including 3-dimensional biogel scaffolds,growth factors, hormones and other culture conditions, will be investigated as they relate to successful maturation of immature follicles obtained from ovarian tissue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification	NCT01839045	Breast Cancer		25 Years - 49 Years	Provista Diagnostics, Inc
Ovarian Freezing Before Cancer Treatment	NCT01057745	Effects of Chem...		18 Years - 42 Years	University of Pennsylvania

Spots Global Cancer Trial Database for woman

Every month we try and update this database with for woman cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for woman

Every month we try and update this database with for woman cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for woman cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.