NL-OMON44465
Recruiting
Not Applicable
Investigating cardiovascular adverse events related to cancer treatment: a study of extreme toxicity using induced pluripotent stem cells - InvestiCAT-iPSC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cardiovascular adverse events after cancer treatment
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. any proven cancer treated with curative intent;
- •2\. age \>\= 18 and \<\= 50 years;
- •3\. able to comply with the protocol;
- •4\. signed written informed consent.
- •Furthermore, there are specific inclusion criteria for every subject group:
- •\[A\-TOX]: severe cardiovascular toxicity\* during 1 to 3 cycles of anthracyclines (i.e. 60 to 180 mg/m2 doxorubicin or 90 to 270 mg/m2 epirubicin);
- •\[A\-NO]: \>\= 3 months after end of cancer treatment which included the maximum tolerable dose of anthracyclines (i.e. 450 to 500 mg/m2 doxorubicin or 850 to 900 mg/m2 epirucibin);
- •\[T\-TOX]: severe cardiovascular toxicity\* within 1 to 6 cycles of trastuzumab (6 mg/kg/3wks or equivalent);
- •\[T\-NO]: \>\= 3 months after end of cancer treatment which included a year of trastuzumab (18 cycles of 6 mg/kg/3wks or equivalent).
- •\[C\-TOX]: severe cardiovascular toxicity\* during 1 to 3 cycles of cisplatin (i.e. 100 to 300 mg/m2\);
Exclusion Criteria
- •1\. history of cardiovascular disease prior to start of cancer treatment, as evidenced by any of the following:
- •a. symptomatic or treated cardiovascular disease prior to start of cancer treatment;
- •b. LVEF \< 55% at any performed MUGA scan or echocardiography prior to start of cancer treatment;
- •2\. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, or insufficient understanding of the Dutch language;
- •3\. any contraindication for skin biopsy, including:
- •a. extensive skin disorder precluding biopsy of unaffected skin;
- •b. known allergy to local anesthetics;
- •4\. use of anticoagulants and INR \> 3;
- •5\. pregnant or lactating female.
- •Furthermore, there are specific exclusion criteria for the \*resilient\* subject groups \[A\-NO], \[T\-NO], \[C\-NO], and \[B\-NO]:
Outcomes
Primary Outcomes
Not specified
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