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Evaluation of Side Effects of Mitotane

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Wuerzburg
Sponsor:
Information provided by (Responsible Party):
Martin Fassnacht, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00568139
First received: December 4, 2007
Last updated: October 28, 2016
Last verified: October 2016
  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 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mitotane
Patients with adrenocortical carcinoma treated with mitotane
Control
Patients with adrenocortical carcinoma not treated with mitotane

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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

Responsible Party: Martin Fassnacht, Head of Endocrinology, 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: October 28, 2016
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on December 02, 2016