Involvement of Endogenous Digitalis-like Compounds in Breast Cancer

NCT00310882 | Withdrawn

• 1 other identifier: 297-31.3-06-HMO-CTIL
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms; Fibrocystic Disease of Breast; Mammaplasty

Keywords

breast cancer; digitalis like compounds; prognostic factor

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University Medical Centers

Jerusalem, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Breast Neoplasms; Fibrocystic Breast Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Heidrun Weideman

  Hadassah Hebrew University Medical Centers

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 4, 2006
• First Posted: April 5, 2006
• Study Start: May 1, 2006
• Study Completion: May 1, 2008
• Last Updated: April 8, 2011

Record last verified: 2008-05

Locations

IL (1)