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Could being male or female change how a thyroid cancer drug works?

NCT ID NCT05789667

Knowledge-focused Sponsor: Regina Elena Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study looks at whether men and women with a certain type of advanced thyroid cancer (radioiodine-refractory differentiated thyroid cancer) experience different side effects and outcomes when treated with the drug lenvatinib. Researchers will compare dose reductions, side effects, and response rates between the sexes. The goal is to see if gender plays a role in how well the drug works and how it is tolerated, which could help personalize treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenvatinib (Lenvima), an oral targeted therapy for advanced thyroid cancer
What this could lead to
If gender differences are found, doctors could tailor lenvatinib dosing and monitoring to improve safety and outcomes for both men and women.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may be influenced by other factors, and the findings may not change clinical practice without further research.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

138 people

The number who actually took part.

Started

May 2020

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients affected by radio-refractory iodine differentiated thyroid cancer

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with refractory iodine DTC treated with lenvatinib * Signed written informed consent Exclusion Criteria: \- Age \< 18 years

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Conditions

The condition(s) this trial relates to.

Coitus differentiated thyroid carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Differentiated thyroid cancer GENDER

Contacts and locations

Locations

  • Regina Elena National Cancer Institute

    Rome, 00144, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.