Investigating heart problems caused by cancer treatments
Investigating Cardiovascular Adverse Events Related to Cancer Treatment: a Study of Extreme Toxicity Using Induced Pluripotent Stem Cells
This study is trying to understand why some cancer treatments cause heart problems in patients by looking at heart cells made from their own stem cells.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (Groningen) |
| Trial ID | NCT03199300 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the cardiovascular toxicity associated with cancer treatments such as cisplatin, anthracyclines, bleomycin, and trastuzumab. By using induced pluripotent stem cells derived from patients, researchers will mimic and study the pathological cardiovascular responses and toxicity in vitro. The goal is to unravel why some patients experience severe cardiovascular side effects from these treatments, which could lead to better management of long-term cardiovascular health in cancer survivors.
Who should consider this trial
Good fit: Ideal candidates are cancer patients aged 18 to 50 who have experienced severe toxicity from specific cancer treatments.
Not a fit: Patients who have not experienced severe toxicity from the specified cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in cancer patients, enhancing their long-term health outcomes.
How similar studies have performed: While there have been studies on chemotherapy-related toxicity, this specific approach using patient-derived cells to study cardiovascular responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of these 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. There are specific inclusion criteria for every subject group: * severe toxicity during 1 to 3 cycles of anthracyclines; * ≥ 3 months after end of cancer treatment which included the maximum tolerable dose of anthracyclines without (severe) toxicity; * severe toxicity within 1 to 6 cycles of trastuzumab; * ≥ 3 months after end of cancer treatment which included a year of trastuzumab without (severe) toxicity. * severe toxicity during 1 to 3 cycles of cisplatin; * ≥ 1 year after end of cancer treatment which included high-dose cisplatin without toxicity; * severe toxicity during 1 to 3 cycles of bleomycin; * ≥ 1 year after end of cancer treatment which included high-dose bleomycin without toxicity. Severe toxicity is defined as any of grade 3 - 4 toxicity according to CTCAE 4.03. A potential subject who meets any of the following exclusion criteria will be excluded from participation in this study: 1. history of cardiovascular disease prior to start of cancer treatment, as evidenced by any of the following: symptomatic or treated cardiovascular disease prior to start of cancer treatment; 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: extensive skin disorder precluding biopsy of unaffected skin; known allergy to local anaesthetics; use of anticoagulants and INR \> 3; 4. pregnant or lactating female. Furthermore, there are specific exclusion criteria for the control groups: 5. history of cardiovascular disease during or after cancer treatment, as evidenced by any of the following: any symptomatic or treated cardiovascular disease; LVEF \< 55% at any performed MUGA scan or echocardiography.
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: J.A. Gietema, MD, PhD — University Medical Center Groningen
- Study coordinator: J.A. Gietema, MD, PhD
- Email: j.a.gietema@umcg.nl
- Phone: +31 50 3612821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.