Toxicity Due to ChemotherapyInvestiCATNCT03199300
Investigating Cardiovascular Adverse Events Related to Cancer Treatment
An observational study of Toxicity Due to Chemotherapy and Cardiovascular Morbidity, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Cisplatin, anthracyclines, bleomycin and trastuzumab can cause severe cardiovascular or pulmonary toxicity. Why some patients are susceptible to extreme toxicity of cancer treatment is largely unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toxicity Due to Chemotherapy, Cardiovascular Morbidity, Cancer, Treatment-Related
- What is being tested?
- Anthracyclines, Trastuzumab and Cisplatin
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Dec 2017to Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for a malignancy with any of the described cytotoxic agents.
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of these criteria:
- any proven cancer treated with curative intent;
- age ≥ 18 and ≤ 50 years;
- able to comply with the protocol;
- signed written informed consent.
- There are specific inclusion criteria for every subject group:
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- 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:
- 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;
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, or insufficient understanding of the Dutch language;
- 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;
- pregnant or lactating female.
- Furthermore, there are specific exclusion criteria for the control groups:
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Cardiovascular Adverse Events Related to Cancer Treatment: a Study of Extreme Toxicity Using Induced Pluripotent Stem Cells
Cisplatin, anthracyclines, bleomycin and trastuzumab can cause severe cardiovascular or pulmonary toxicity. Why some patients are susceptible to extreme toxicity of cancer treatment is largely unknown. Unraveling extreme cardiovascular toxic responses in cancer patients may help understand the pathophysiology of cardiovascular toxicity of these agents and help in understanding the more subtle, long-term cardiovascular side effects that affect a larger part of cancer survivors. With induced pluripotent stem cells we will obtain patient-derived cells to recapitulate and mimic and study pathological (cardiovascular) responses and (cardiovascular) toxicity in vitro.
- Being tested
- Anthracyclines, Trastuzumab, Cisplatin, Bleomycin
- Keywords
- bleomycin, cisplatin, trastuzumab, anthracyclines, toxicity
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthracyclinesDrug
Chemotherapy regimen containing anthracyclines.
TrastuzumabDrug
Systemic treatment including trastuzumab.
CisplatinDrug
Chemotherapy including cisplatin.
BleomycinDrug
Chemotherapy including bleomycin.
| Study group | Role | What they receive |
|---|---|---|
| Anthracylines-treated with toxicity | Patients with toxicity during/after treatment with anthracylines. Receives: Drug: Anthracyclines | |
| Anthracyclines-treated without toxicity | Patients without toxicity during/after treatment with anthracylines. Receives: Drug: Anthracyclines | |
| Trastuzumab-treated with toxicity | Patients with toxicity during/after treatment with trastuzumab. Receives: Drug: Trastuzumab | |
| Trastuzumab-treated without toxicity | Patients without toxicity during/after treatment with trastuzumab. Receives: Drug: Trastuzumab | |
| Cisplatin-treated with toxicity | Patients with toxicity during/after treatment with cisplatin. Receives: Drug: Cisplatin | |
| Cisplatin-treated without toxicity | Patients without toxicity during/after treatment with cisplatin. Receives: Drug: Cisplatin | |
| Bleomycin-treated with toxicity | Patients with toxicity during/after treatment with bleomycin. Receives: Drug: Bleomycin | |
| Bleomycin-treated without toxicity | Patients without toxicity during/after treatment with bleomycin. Receives: Drug: Bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between iPSC-derived cells
Comparison between iPSC-derived cells from toxicity cases and controls, for each of the four different agents.
Measured: 3 years
Secondary outcomes (1)
Correlate the findings from the iPSC-derived cells with the clinical phenotype of cardiovascular toxicity
Correlate the findings from the iPSC-derived cells with the clinical phenotype of (cardiovascular) toxicity, assessed by circulating biomarkers and cardiac or vascular imaging.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start12 Dec 2017
- Primary completion6 Feb 2025
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicity Due to ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J.A. Gietema, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199300
- Sponsor's protocol ID
- 201700454
- Acronym
- InvestiCAT
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2017
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No