NCT00331942

Brief Summary

To determine the ability of the Cimmunology process to lead to in vitro antibody production, the ability of the ELISA assays to detect any of those antibodies, and to establish the relationship between the ELISA results and the clinical / pathological status of the patient. The statistical significance of the CAAb test results will be determined.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 2, 2007

Status Verified

April 1, 2006

First QC Date

May 27, 2006

Last Update Submit

March 1, 2007

Conditions

Breast Cancer

Keywords

BreastCancerAssociatedAntibodies

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 18 years or over.
  • Patients diagnosed with suspected breast cancer, (positive mammography or ultrasound or physical examination) and have a positive biopsy.
  • Patients willing to participate as evidenced by signing the written informed consent.

You may not qualify if:

  • Subjects less than 18 years
  • Patients with prior history of other tumors (except skin cancer)
  • Hematologic systemic disorders
  • Patients that have undergone chemotherapy
  • Patients that have been under anesthesia in the last three months.
  • Patient not willing to sign written informed consent.
  • Subjects 18 years or over
  • Patients willing to participate as evidenced by signing the written informed consent
  • Subjects had a negative mammography in the past three months.
  • Subjects less than 18 years
  • Hematological malignancies
  • History of any past tumors
  • Other breast pathology
  • Patients that have been under anesthesia in the last three months
  • Patients treated with immuno-suppressant drugs
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Soroka

Beersheba, Israel

RECRUITING

Carmel Medical center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tamar J Cohen, Phd.

    Lab Discoveries

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Hayka

CONTACT

+972 544 631237alonhayka@yahoo.com

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2006

First Posted

May 31, 2006

Study Start

July 1, 2006

Study Completion

May 1, 2008

Last Updated

March 2, 2007

Record last verified: 2006-04

Locations

IL(2)