CompletedPhase 3

CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial

France175 participantsStarted 2008-10

Plain-language summary

Heart transplant is a recognized therapeutic strategy in refractory heart failure. Its success is however hampered by severe cancer occurrence and recurrence. The new m-tor inhibiting drugs Sirolimus and Everolimus have shown potential for reducing the incidence of cancer in animal models. They are potent immunosuppressant, antiproliferative and antiangiogenic drugs. This open labelled randomized multicenter study aims at evaluating the beneficial antineoplastic effect of Everolimus in 159 heart transplant patients suffering of recurrent skin cancer. Primary objective is to demonstrate a reduction in the number of new skin cancers. Secondary end point will be time of recurrence, incidence of non skin cancer, graft function following switch (including death), renal function evolution following calcineurin inhibitors reduction or withdrawal, Everolimus tolerance profile, schemes of calcineurin inhibitors reduction management in centers.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of skin tumors per patients requiring surgery with histology control within 2 years

Timeframe: 2 years

Trial details

NCT IDNCT00799188

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-08

View on ClinicalTrials.gov More Cardiac Transplantation trials