Involvement of Endogenous Digitalis-like Compounds in Breast Cancer

This study has been withdrawn prior to enrollment.
(the PI is no longer work at Hadassah)
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00310882
First received: April 4, 2006
Last updated: April 7, 2011
Last verified: May 2008
  Purpose

The endogenous digitalis-like compounds (DLC)are steroid hormones synthesized and released from the adrenal gland.They are integrated in the feed-back system of the Hypothalami-Pituitary-Adrenal gland axis.One of their remarkable function is to induce apoptosis in malignant cells. Recently, accumulating data point to the possibility of using synthetic DLC as new anti-cancer drugs. Less is known about the endogenous metabolism of these compounds in cancer patients.

Proceeding from preliminary clinical data which demonstrated significantly reduced DLC plasma levels in breast cancer patients and from in vitro data which showed an impaired release of DLC towards stress stimuli in athymic nude mice,we put up the hypothesis that a latent adrenal insufficiency with low DLC levels facilitates the induction and progression of tumor diseases.


Condition
Breast Neoplasms
Fibrocystic Disease of Breast
Mammaplasty

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Involvement of Endogenous Digitalis-like Compounds in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples Without DNA

blood samples


Estimated Enrollment: 250
Study Start Date: May 2006
Estimated Study Completion Date: May 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Women with first diagnosis of Breast Cancer or a benign Breast Disease

Criteria

Inclusion Criteria:

  • first visit to a Breast Disease Ambulance for consultation
  • no pregnancy

Exclusion Criteria:

  • no severe heart disease (EF > 40%)
  • no therapy with digitalis
  • no acute/chronic inflammatory disease (e.g. RA, M. Crohn)
  • no dysfunction of the Hypothalamo-Pituitary-Adrenal system
  • no severe mental disorder
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00310882

Locations
Israel
Hadassah Hebrew University Medical Centers
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Heidrun Weideman Hadassah Hebrew University Medical Centers
  More Information

No publications provided

Responsible Party: Dr. Tanir Allweiss, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00310882     History of Changes
Other Study ID Numbers: 297-31.3-06-HMO-CTIL
Study First Received: April 4, 2006
Last Updated: April 7, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
breast cancer
digitalis like compounds
prognostic factor

Additional relevant MeSH terms:
Breast Neoplasms
Cystic Fibrosis
Fibrocystic Breast Disease
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 30, 2014