Evaluation of Side Effects of Mitotane
This study is currently recruiting participants.
Verified July 2010 by University of Wuerzburg
Sponsor:
University of Wuerzburg
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00568139
First received: December 4, 2007
Last updated: July 6, 2010
Last verified: July 2010
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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
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 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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013