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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00310882
First Posted: April 5, 2006
Last Update Posted: April 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 4, 2006
First Posted: April 5, 2006
Last Update Posted: April 8, 2011
Last Verified: May 2008

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