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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Adrenocortical Carcinoma

Intervention / Treatment
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* Drug: Mitotane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An individual being investigated for a malignant neoplasm treated with mitotane or matched number of patients with adrenal neoplasm not treated with mitotane under the Endocrinology team or a matched cohort of pregnant women. Patients included in the analysis were seen in the period between April of 2019 and June 2020 at King's College Hospital NHS Foundation Trust. - Exclusion Criteria: Patients not investigated for a malignant neoplasm/ adrenal neoplasm under the Endocrinology team or were a matched cohort of pregnant women at King's College Hospital NHS Foundation Trust during the period Someone under the age of 18

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACC on mitotane<br>Individuals in this group were under care by the Endocrinology Team with a diagnosis of an ACC and on mitotane. These individuals were further divided into 3 groups, depending on whether they had a mitotane plasma concentration, within (14-20mg/L), above or below the therapeutic concentration range. | Drug: Mitotane<br>* Individuals within the intervention group were on mitotane therapy as part of their ACC treatment.<br>|
| Adrenal neoplasm without mitotane<br>Individuals within this category had an adrenal neoplasm and were not being treated with mitotane therapy. | |
| Pregnant group<br>Individuals did not have an adrenal neoplasm during this period, nor were they being treated with mitotane. These were healthy pregnant females, who were under the care at KCL during their pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the effect of mitotane therapy on serum thyroid and cortisol binding proteins in patients with ACC | The primary objective of this project is to determine the effects of mitotane therapy on serum thyroid binding and cortisol binding protein concentrations in patients with adrenocortical carcinoma and compare concentrations of the same binding proteins in patients with adrenal neoplasms not on treatment with mitotane and to a cohort of pregnant women. | April 2019-June 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACC, mitotane, adrenocortical carcinoma, serum free proteins, cortisol binding globulin, thyroid binding globulin