Evaluation of Side Effects of Mitotane

This study is not yet open for participant recruitment.

Verified by University of Wuerzburg, December 2007

Sponsored by:	University of Wuerzburg
Information provided by:	University of Wuerzburg
ClinicalTrials.gov Identifier:	NCT00568139

Purpose

Mitotane is standard therapy in the treatment of adrenocortical carcinoma. However, many side effects are not well documented. Therefore, we are aiming at collecting data about side effects in patients treated with mitotane

Condition
Adrenocortical Carcinoma

Drug Information available for: Epinephrine Epinephrine bitartrate Mitotane

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Evaluierung Von Nebenwirkungen Einer Therapie Mit Mitotane Beim Nebennierenkarzinom- Evaluation of Side Effects of Mitotane in Adrenocortical Carcinoma

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:

Documentation of side effects [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum, plasma, and urine samples will be collected.

Estimated Enrollment:	200
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010

Groups/Cohorts
Mitotane Patients with adrenocortical carcinoma treated with mitotane
Control Patients with adrenocortical carcinoma not treated with mitotane

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with adrenocortical carcinoma treated in our center

Criteria

Inclusion Criteria:

Adrenocortical carcinoma
Treatment with mitotane intended or mitotane administered

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568139

Contacts

Contact: Martin Fassnacht, MD	+49-931-201-36507	fassnacht_m@medizin.uni-wuerzburg.de
Contact: Stefanie Hahner, MD	+49-931-201-36508	hahner_s@medizin.uni-wuerzburg.de

Locations

Germany
University Hospital
Wuerzburg, Germany, 97080

Sponsors and Collaborators

University of Wuerzburg

Investigators

Principal Investigator:

Martin Fassnacht, MD

University of Wuerzburg

More Information

Responsible Party:	University of Wuerzburg ( Martin Fassnacht )
Study ID Numbers:	Wue-ACC-Mitotane
Study First Received:	December 4, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00568139
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Wuerzburg:

adrenal cancer
mitotane (Lysodren)
adverse events

Study placed in the following topic categories:

Adrenocortical Carcinoma
Adrenocortical carcinoma
Adrenal Gland Diseases
Endocrine System Diseases
Mitotane
Carcinoma
Adrenal Gland Neoplasms

Adrenal Cortex Neoplasms
Endocrinopathy
Epinephrine
Adenocarcinoma
Adrenal Cortex Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009