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Completed

NCT Number: NCT05344027

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

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.

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Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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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

Treatment and study plan

Mitotane

Drug

Individuals within the intervention group were on mitotane therapy as part of their ACC treatment.

Primary outcomes

  1. Examine the effect of mitotane therapy on serum thyroid and cortisol binding proteins in patients with ACC

    Time frame: April 2019-June 2020

    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.

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Acronym: MitoS-FP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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