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Evaluation of Side Effects of Mitotane

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ClinicalTrials.gov Identifier: NCT00568139
Recruitment Status : Recruiting
First Posted : December 5, 2007
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Adrenocortical Carcinoma

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : January 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Mitotane
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Mitotane
Patients with adrenocortical carcinoma treated with mitotane
Control
Patients with adrenocortical carcinoma not treated with mitotane


Outcome Measures

Primary Outcome Measures :
  1. Documentation of side effects [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
Serum, plasma, and urine samples will be collected.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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): 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
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

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

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