Cardiac TransplantationPhase 3CERTICOEURNCT00799188
CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial
A Phase 3 study testing Everolimus in people with Cardiac Transplantation and Skin Cancer, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Transplantation, Skin Cancer
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial
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.
Read the detailed 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
- Conditions
- Cardiac Transplantation, Skin Cancer
- Being tested
- Everolimus
- Keywords
- Cardiac Transplantation, Skin cancer, Everolimus
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican
50% reduction of calcineurin inhibitors daily dose followed by further decrease or withdrawal. Everolimus will be introduced and tapered to a trough level of 6 to 10 microg/l.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | reduction of immunosuppression |
| 2 | Experimental | switch to Everolimus : 50% reduction of calcineurin inhibitors (ciclosporine or tacrolimus) Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of skin tumors per patients requiring surgery with histology control within 2 years
Measured: 2 years
Secondary outcomes (10)
New skin cancer
Measured: 2 years
Number of patients with new skin cancers
Measured: 2 years
Time of recurrence
Measured: 2 years
Number and histology of other types of skin cancer
Measured: 2 years
Graft function (including acute rejection, graft loss, death)
Measured: 2 years
Renal function evolution as assessed using Cockcroft creatinine clearance and proteinuria
Measured: 2 years
Adverse events and serious adverse events
Measured: 2 years
Non skin cancer (Number and diagnostic)
Measured: 2 years
Schemes of calcineurin inhibitors reduction/withdrawal
Measured: 2 years
Immune response assessment through regulatory or effector function of blood and in situ T lymphocytes at baseline and following immunosuppression switch
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAURENT SEBBAG, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799188
- Sponsor's protocol ID
- 2007.489/32
- Acronym
- CERTICOEUR
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2008
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial
- ClinicalTrials.gov ID
- NCT00799188
- Acronym / sponsor ID
- CERTICOEUR / 2007.489/32
- Conditions
- Cardiac Transplantation, Skin Cancer
- Keywords
- Cardiac Transplantation, Skin cancer, Everolimus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2014 (actual)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –reduction of immunosuppression |
| 2 | Experimental | Drug: Everolimusswitch to Everolimus : 50% reduction of calcineurin inhibitors (ciclosporine or tacrolimus) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- Other non simultaneously transplanted organ
- recent biopsy proven acute rejection
- Proteinuria > 1g/l
- Ongoing infectious disease
- HIV positivity, Chronic active Hepatitis B or C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverolimusAlso: Certican50% reduction of calcineurin inhibitors daily dose followed by further decrease or withdrawal. Everolimus will be introduced and tapered to a trough level of 6 to 10 microg/l. | Drug | 2 |
Primary outcome
Number of skin tumors per patients requiring surgery with histology control within 2 years
Time frame: 2 years
10 secondary outcomes
New skin cancer
Time frame: 2 years
Number of patients with new skin cancers
Time frame: 2 years
Time of recurrence
Time frame: 2 years
Number and histology of other types of skin cancer
Time frame: 2 years
Graft function (including acute rejection, graft loss, death)
Time frame: 2 years
Renal function evolution as assessed using Cockcroft creatinine clearance and proteinuria
Time frame: 2 years
Adverse events and serious adverse events
Time frame: 2 years
Non skin cancer (Number and diagnostic)
Time frame: 2 years
Schemes of calcineurin inhibitors reduction/withdrawal
Time frame: 2 years
Immune response assessment through regulatory or effector function of blood and in situ T lymphocytes at baseline and following immunosuppression switch
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAURENT SEBBAG, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus in people with Cardiac Transplantation and Skin Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of skin tumors per patients requiring surgery with histology control within 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.