Brief Title
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
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).
Study Type
Observational
Primary Outcome
Examine the effect of mitotane therapy on serum thyroid and cortisol binding proteins in patients with ACC
Condition
Adrenocortical Carcinoma
Intervention
Mitotane
Study Arms / Comparison Groups
ACC on mitotane
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
35
Start Date
April 11, 2022
Completion Date
May 13, 2022
Primary Completion Date
May 12, 2022
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.
-
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
Gender
All
Ages
19 Years - 85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT05344027
Organization ID
GafREC-Endo202
Responsible Party
Sponsor
Study Sponsor
King's College Hospital NHS Trust
Study Sponsor
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Verification Date
April 2022