Full Text View
Tabular View
No Study Results Posted
Related Studies
Involvement of Endogenous Digitalis-Like Compounds in Breast Cancer
This study is currently recruiting participants.
Verified by Hadassah Medical Organization, May 2008
First Received: April 4, 2006   Last Updated: May 12, 2008   History of Changes
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00310882
  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

Genetics Home Reference related topics: breast cancer cystic fibrosis
MedlinePlus related topics: Breast Cancer Breast Diseases Cancer Cystic Fibrosis
Drug Information available for: Digitalis
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Involvement of Endogenous Digitalis-Like Compounds in Breast Cancer

Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310882

Contacts
Contact: Heidrun Weideman, MD +972-50-8946378 hweidemann@freenet.de
Contact: Tanir Allweis, MD +972-50-787-4268 tanir@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Medical Centers Recruiting
Jerusalem, Israel
Principal Investigator: Heidrun Weidemann, MD            
Sub-Investigator: Tanir M Allweis, MD            
Sub-Investigator: Asher Salmon, MD            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Heidrun Weideman Hadassah Hebrew University Medical Centers
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization ( Dr. Tanir Allweiss )
Study ID Numbers: 297-31.3-06-HMO-CTIL
Study First Received: April 4, 2006
Last Updated: May 12, 2008
ClinicalTrials.gov Identifier: NCT00310882     History of Changes
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Study placed in the following topic categories:
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Skin Diseases
Fibrocystic Breast Disease
Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Breast Neoplasms
Breast Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009