NCT05344027

The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This work will evaluate the effects of mitotane treatment on serum protein concentrations in patients treated for ACC with mitotane therapy and compare them to patients with an adrenal neoplasm and pregnant cohort. All of the individuals were treated at King's Hospital between April 2019 and June 2020. Proteins which will be evaluated during this study, include CBG and TBG.

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 effects of mitotane treatment on serum protein concentrations in patients treated for ACC with mitotane therapy and compare to patients with an adrenal neoplasm and a pregnant cohort. Patients were treated at King's Hospital between April 2019 and June 2020. Methods: Cortisol, TFT's ACTH, CBG, TBG and gonadotrophins will be measured during the same venepuncture using serum samples. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Thirty-five patients will be included, within ACC with mitotane, adrenal neoplasm or pregnant groups. 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).

Conditions

• Adrenocortical Carcinoma

Interventions

Type	Name	Description
DRUG	Mitotane	Individuals within the intervention group were on mitotane therapy as part of their ACC treatment.

Timeline

• Start date: 2022-04-11
• Primary completion: 2023-01-30
• Completion: 2023-03-01
• First posted: 2022-04-25
• Last updated: 2023-03-08

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study