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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00799188 |
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Date of registration:
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26/11/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial
CERTICOEUR |
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Scientific title:
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CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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175 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00799188 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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LAURENT SEBBAG, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Skin Cancer
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Cardiac Transplantation
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Intervention(s)
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Drug: Everolimus
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Primary Outcome(s)
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Number of skin tumors per patients requiring surgery with histology control within 2 years
[Time Frame: 2 years]
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Secondary Outcome(s)
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Number and histology of other types of skin cancer
[Time Frame: 2 years]
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Adverse events and serious adverse events
[Time Frame: 2 years]
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Number of patients with new skin cancers
[Time Frame: 2 years]
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Renal function evolution as assessed using Cockcroft creatinine clearance and proteinuria
[Time Frame: 2 years]
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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]
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Non skin cancer (Number and diagnostic)
[Time Frame: 2 years]
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Time of recurrence
[Time Frame: 2 years]
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Graft function (including acute rejection, graft loss, death)
[Time Frame: 2 years]
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New skin cancer
[Time Frame: 2 years]
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Schemes of calcineurin inhibitors reduction/withdrawal
[Time Frame: 2 years]
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Secondary ID(s)
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2007.489/32
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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