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Trial Title:
The Adverse Event of Mitotane Therapy in Patients With Adrenocortical Carcinoma
NCT ID:
NCT05839886
Condition:
Adrenocortical Carcinoma
Conditions: Official terms:
Carcinoma
Adrenocortical Carcinoma
Conditions: Keywords:
Mitotane
Adverse effect
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
This work will evaluate the adverse effects of mitotane treatment in patients treated for
ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between
May 2023 and May 2024.
Detailed description:
Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex.
The annual incidence of ACC is thought to be between 0.5-2.0 cases per million.
Adjunctive therapy with mitotane may be offered post- surgically to minimise risk of
recurrence.
Aims: Evaluate the adverse effects of mitotane treatment in patients treated for ACC with
mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023
and May 2024.
Methods: Cortisol, ACTH, Gastrointestinal reactions and CNS Toxicity will be measured.
SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Patients
will be included, within ACC with mitotane. Data will be tested for normality, described
as Mean± SD, compared using paired sample t-test with 5% p-value for significance and 95%
confidence interval (CI).
Criteria for eligibility:
Study pop:
Patients with adrenocortical carcinoma treated with mitotane
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Age ≥ 18 years old and ≤ 75 years Diagnosis of Patients with adrenocortical cancer
Gender: males and females Provide written informed consent Satisfactory compliance
Exclusion Criteria:
Patients with renal insufficiency (Cr>2 times the upper limit of normal). Patients with a
history of liver cirrhosis. Patients who are currently using corticosteroids. Patients
with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or
EF<50%).
Patients with stroke and acute myocardial infarction in the past 6 months. Patients
during pregnancy and lactation
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05839886
