Stem cells may unlock mystery of chemo-related heart damage
NCT ID NCT03199300
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study uses stem cells made from patients' own cells to understand why some people develop severe heart or lung side effects from certain chemotherapy drugs. Researchers will compare cells from patients who had extreme toxicity to those who did not. The goal is to uncover the root causes of these side effects and improve long-term care for cancer survivors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors predict which patients are at risk for heart damage from chemotherapy, leading to safer, personalized cancer treatments.
- What could go wrong
- This is a small, early-stage study with only 20 participants, so results may not apply to everyone. It is observational and does not test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
20 people
The number who actually took part.
- Started
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Dec 2017
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients treated for a malignancy with any of the described cytotoxic agents.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
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