Evaluation the Diagnostic Ability of the Cancer Detection Technology (CDT) to Detect Breast Cancer Among Women Population Over Age 40

NCT01043055 | Unknown

• 1 other identifier: 044809-HMO-CTIL
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to validate the diagnostic ability of the CDT (cancer detection technology) software to detect breast cancer among women population.

Conditions

Breast Cancer

Keywords

Breast Cancer Screening

Outcome Measures

Primary Outcomes (1)

• To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40

  one year

Secondary Outcomes (2)

• To correlate the technology with standard test - screening mammography and biopsy

  two years

• To validate and compare the diagnostic ability of the CDT for detection of breast cancer

  two years

Study Arms (2)

Breast Cancer Patients

Healthy Control Group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients over age 40 before treatment. Healthy women recruited in Check Up institute from asymptomatic women over age 40, referred to screening mammography and received the negative result of mammography.

You may qualify if:

• Patient is over the age of 40.
• Patient is willing to participate as evidenced by signing the written informed consent form.
• Patient referred to the Department of Oncology/ Surgery for operative treatment of breast cancer with previously detected disease. Positive conventional tests finding can include (but not limited to) the record of screening or diagnostic mammography, blood oncomarkers, breast ultrasound, breast CT, biopsy.
• Non-treated patients (w/o previous chemotherapy, hormonal drugs and radiotherapy).
• Patient without other cancer locations
• Subjects over the age of 40.
• Subjects who are willing to participate as evidenced by signing the written informed consent form.
• Subjects who are presumably healthy and without breast pathologies' symptoms and family history of breast cancer, i.e., breast disease (except history of functional breast problems, e.g., mastitis within lactation period) has been ruled out based on physician anamnesis
• Subjects with negative results of screening mammography.
• Subjects without taking of any hormonal medicines

You may not qualify if:

• Subjects with any known cancer in other internal organs or systems.
• Subjects with high fever presentation (more than 38.5).
• Subjects with known breast disease undergoing treatment for the disease.
• Pregnant or lactating women

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Jerusalem, 91120, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tamar Peretz, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamar Peretz, MD

CONTACT

6777825; tamary@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

6777572; lhadas@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2011
• Last Updated: January 6, 2010

Record last verified: 2009-10

Locations

IL (1)