NCT00568139

Brief Summary

Mitotane is standard therapy in the treatment of adrenocortical carcinoma. However, many adverse effects are not well documented. Therefore, we are aiming at collecting data about adverse effects in patients treated with mitotane

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2008Dec 2027

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
17.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

August 26, 2025

Status Verified

September 1, 2024

Enrollment Period

17.9 years

First QC Date

December 4, 2007

Last Update Submit

August 24, 2025

Conditions

Adrenocortical Carcinoma

Keywords

adrenal cancermitotane (Lysodren)adverse events

Outcome Measures

Primary Outcomes (1)

  • Documentation of adverse effects

    Adverse effects will be documented using the NCI CTC AE v5.5

    from starting mitotane until discontinuation of mitotane (since this is very variable from patient to patient no specific number of days or weeks can be entered (standard therapy would be about 2 years) or start of additional other medical therapies

Study Arms (1)

Mitotane

Patients with adrenocortical carcinoma treated with mitotane monotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with adrenocortical carcinoma treated in our center or other ENSAT centers

You may qualify if:

  • Adrenocortical carcinoma
  • Treatment with mitotane monotherapy as first-line therapy (in adjuvant setting or advanced disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Würzburg, 97080, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, and urine samples will be collected.

MeSH Terms

Conditions

Adrenocortical CarcinomaAdrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdrenal Cortex NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Martin Fassnacht, MD

    University of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Endocrinology

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

August 26, 2025

Record last verified: 2024-09

Locations

DE(1)