Selpercatinib and Body Composition | NCT07543887

Studies
Selpercatinib and Body Composition

NCT07543887

Sponsor

University of Pisa

Status

Completed

Last Update Posted

Apr 22, 2026Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Thyroid Cancer

Interventions

observation in patient under treatment
Selpercatinib

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
university hospital of pisa	Other Identifier	university hospital of pisa

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2024Actual

Primary Completion Date

Apr 4, 2026Actual

Completion Date

Apr 4, 2026Actual

First Submitted Date

Apr 5, 2026

First Submission Date that Met QC Criteria

Apr 14, 2026

First Posted Date

Apr 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2026

Last Update Posted Date

Apr 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient with advanced medullary thyroid cancer		patient with advanced medullary thyroid cancer	Other: observation in patient under treatment Drug: Selpercatinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation in patient under treatment	Other	observation in patient under treatment	patient with advanced medullary thyroid cancer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Inability to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with thyroid cancer receiving ongoing treatment with selpercatinib

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Pisa		Pisa	PI	56124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms
D013959	Thyroid Diseases

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation
C000656166	selpercatinib

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided