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Heart transplant drug may also fight skin cancer

NCT ID NCT00799188

Disease control Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the drug everolimus can reduce new skin cancers in heart transplant patients who already had skin cancer. 175 participants received either everolimus or standard immunosuppressants. The goal was to see if everolimus lowers the number of new skin tumors needing surgery over two years.

What this could mean

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

Active substance
everolimus
What this could lead to
If successful, this could offer heart transplant patients a way to lower their risk of recurrent skin cancers while maintaining graft function.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. Everolimus has side effects and may not prevent all skin cancers or other cancers.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

175 people

The number who actually took part.

Start date

Oct 2008

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.

Ages

18 to 65 years

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: * First orthotopic heart transplant after 1st year * No rejection within previous 6 Months * Occurrence of squamous cell carcinoma, basal cell carcinoma, in situ carcinoma, Bowen disease, premalignant keratosis * Recurrence of skin cancers leading to immunosuppressive regimen modifications * Removal of a skin lesion in the past three years * Above 18 yrs and under contraceptive drugs if applicable * Informed consent given * Health coverage ongoing Exclusion Criteria: * Other non simultaneously transplanted organ * recent biopsy proven acute rejection * Proteinuria \> 1g/l * Ongoing infectious disease * HIV positivity, Chronic active Hepatitis B or C. * Abnormal blood tests: transaminases \>= 3UNL, Bilirubin \> 34 mmol.l, albumin\<35 g/l, spontaneous INR \>1,3 * Hemoglobin \>= 8 g/dl, White Blood Count\<= 2 giga/l, platelet count \<= 50 giga/l * Hypercholesterolemia\>= 9 mmol/l, hypertriglyceridemia \>= 8,5 mmol/l despite treatment * History of macrolid or mTor inhibitor intolerance * Previous cancer other than skin in the year prior to enrollment * Medical or surgical condition unsuitable for the trial * Breast feeding * Positive pregnancy test * Severe psychiatric disorder * Communication or language disability

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Conditions

The condition(s) this trial relates to.

actinic keratosis basal cell carcinoma Bowen disease of the skin in situ carcinoma precancerous condition skin cancer skin neoplasm squamous cell carcinoma

As listed by the trial registrant

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

Cardiac transplantation Skin cancer

Contacts and locations

Locations

  • HOSPICES CIVILS de LYON

    Lyon, France

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