Advertisement

Topics

OctavaPink for Women With Dense Breast After Negative Mammography

2014-09-17 14:08:21 | BioPortfolio

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.

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Conditions

Breast Cancer

Intervention

MRI

Location

Detroit Clinical Research Center
Detroit
Michigan
United States
48201

Status

Not yet recruiting

Source

Eventus Diagnostics Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-17T14:08:21-0400

Clinical Trials [3930 Associated Clinical Trials listed on BioPortfolio]

A Breast Cancer Information Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer

RATIONALE: Gathering information about patients with breast cancer and their families may help the study of breast cancer in the future. PURPOSE: This clinical trial is gathering informat...

A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China

The purpose of the study is to study the epidemic features and diagnosis of female breast cancer, especially the diagnosis and treatment of breast cancer.The disease-free survival (DFS) an...

Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer

The purpose of this study is to collect a blood sample from patients with breast disease (cases) and from individuals without breast cancer (controls)that may be used for research purposes...

MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery

To see if performing breast MRI before a lumpectomy will help the surgeon successfully remove the entire cancer with normal tissue margins in a single operation thereby reducing the need f...

Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer

Breast cancer is the most common female malignancy in the world, and the leading cause of cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the main...

PubMed Articles [14055 Associated PubMed Articles listed on BioPortfolio]

Breast cancer in octogenarian. Are we doing our best? A population-registry based study.

The number of old people with breast cancer is estimated to increase during the next years in developed countries. However, management of breast cancer in octogenarians is not well established. The ma...

Multiple primary non-breast tumors in breast cancer survivors.

The aim of this study was to assess the frequency of second primary non-breast cancer after breast cancer diagnosis and treatment, and its correlation with clinicopathological features.

Inhibition of miR-155, a therapeutic target for breast cancer, prevented in cancer stem cell formation.

Breast cancer is a common cancer in women of worldwide. Cancer cells with stem-like properties played important roles in breast cancer, such as relapse, metastasis and treatment resistance. Micro-RNA-...

Alcohol consumption and breast cancer-specific and all-cause mortality in women diagnosed with breast cancer at the New York site of the Breast Cancer Family Registry.

Alcohol consumption is an established and important risk factor for breast cancer incidence in the general population. However, the relationship between alcohol and mortality among women with breast c...

New Educational Model to Promote Breast Cancer-Preventive Behaviors (ASSISTS): Development and First Evaluation.

The prevalence of breast cancer in Iran has increased. An effective approach to decrease the burden of breast cancer is prevention.

Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

More From BioPortfolio on "OctavaPink for Women With Dense Breast After Negative Mammography"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...


Searches Linking to this Trial