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Trial record 7 of 14 for:    "Adrenal cancer"

Evaluation of Side Effects of Mitotane

This study is currently recruiting participants.
Verified October 2016 by Martin Fassnacht, University of Wuerzburg
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568139
First Posted: December 5, 2007
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Martin Fassnacht, University of Wuerzburg
  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 Martin Fassnacht, University of Wuerzburg:

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

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

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 Submitted: December 4, 2007
First Posted: December 5, 2007
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:
Carcinoma
Adrenocortical 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