Clinical trial NCT05344027: The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma
Official title: The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenocortical Carcinoma
Keywords: mitotane
adrenocortical carcinoma
ACC
serum free proteins
cortisol binding globulin
thyroid binding globulin
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 13 patients with an ACC on mitotane therapy will be investigated. Median age of the ACC and mitotane group: 63.0 (IQR: 46, 72.5) 22% of the studied population were Caucasian white, 14.3% Southeast Asian, 11.4% Black Afro-Caribbean, 2.9% other and 2.9% missing. 6 (46.2%) of the patients with an ACC and on mitotane were male, and 7 (53.8%) were female. 6 (46.2%) individuals with an ACC and on mitotane had a stage of III and 7 (53.8%) had stage IV (according to the AJCC and ENSAT staging system).

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Examine the effect of mitotane therapy on serum thyroid and cortisol binding proteins in patients with ACC
timeFrame: April 2019-June 2020
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
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