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

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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

, , 


Verification Date

April 2022