Selpercatinib and Body Composition (EECRTKI)

April 14, 2026 updated by: Alessio Basolo, University of Pisa
investigation of body composition

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

investigation of body composition by DXA

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PI
      • Pisa, PI, Italy, 56124
        • University Hospital of Pisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with thyroid cancer receiving ongoing treatment with selpercatinib

Description

Inclusion Criteria:

  • Adults (≥18 years old)
  • Diagnosis of thyroid cancer
  • Ongoing treatment with selpercatinib

Exclusion Criteria:

- Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient with advanced medullary thyroid cancer
Other: observation in patient under treatment
observation in patient under treatment
Drug: Selpercatinib
observational study of patients under selpercatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total lean mass assessed by DXA (kg)
Time Frame: Baseline and 12 months
Total lean body mass measured by dual-energy X-ray absorptiometry
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour energy expenditure (kcal/day)
Time Frame: Baseline and 12 months
Total energy expenditure measured over 24 hours using a whole-room indirect calorimeter
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2024

Primary Completion (Actual)

April 4, 2026

Study Completion (Actual)

April 4, 2026

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EECRTKI
  • university hospital of pisa (Other Identifier: university hospital of pisa)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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