CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

- Open labelled randomized Everolimus vs reduction of calcineurin inhibitors trial. 2:1 randomization design

- October 10, 2008

- 159 patients (106 everolimus vs 53 calcineurin inhibitors reduction)

- 175 patients (117 vs 58)

- X Not yet recruiting 0 recruiting 0 no longer recruiting

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

Within 2 years of Follow up:

- New skin cancer

- Number of patients with new skin cancers

- Time of recurrence

- Number and histology of other types of skin cancer

- Graft function (including acute rejection, graft loss, death)

- Renal function evolution as assessed using Cockcroft creatinine clearance and proteinuria

- Adverse events and serious adverse events

- Non skin cancer (Number and diagnostic)

- Schemes of calcineurin inhibitors reduction/withdrawal

- Immune response assessment through regulatory or effector function of blood and in situ T lymphocytes at baseline and following immunosuppression switch ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00799188
Study type	Interventional
Source	Hospices Civils de Lyon
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	October 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms