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Stem cells may unlock mystery of chemo-related heart damage

NCT ID NCT03199300

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Dec 2017

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

More trials for these conditions

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