Evaluation of Side Effects of Mitotane

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Wuerzburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00568139
First received: December 4, 2007
Last updated: July 6, 2010
Last verified: July 2010
  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

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

Resource links provided by NLM:


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

Serum, plasma, and urine samples will be collected.


Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Wuerzburg, Germany, 97080
Sponsors and Collaborators
University of Wuerzburg
Investigators
Principal Investigator: Martin Fassnacht, MD University of Wuerzburg
  More Information

No publications provided

Responsible Party: Martin Fassnacht, University of Wuerzburg
ClinicalTrials.gov Identifier: NCT00568139     History of Changes
Other Study ID Numbers: Wue-ACC-Mitotane
Study First Received: December 4, 2007
Last Updated: July 6, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Wuerzburg:
adrenal cancer
mitotane (Lysodren)
adverse events

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Carcinoma
Adenocarcinoma
Adrenal Cortex Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Diseases
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Mitotane
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014