Investigating Cardiovascular Adverse Events Related to Cancer Treatment

NCT ID: NCT03199300

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-12
• Study Completion Date: 2027-01-31

Brief 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. 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.

Conditions

Toxicity Due to Chemotherapy; Cardiovascular Morbidity; Cancer, Treatment-Related

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Anthracylines-treated with toxicity

Patients with toxicity during/after treatment with anthracylines.

Anthracyclines

Intervention Type: DRUG

Chemotherapy regimen containing anthracyclines.

Anthracyclines-treated without toxicity

Patients without toxicity during/after treatment with anthracylines.

Anthracyclines

Intervention Type: DRUG

Chemotherapy regimen containing anthracyclines.

Trastuzumab-treated with toxicity

Patients with toxicity during/after treatment with trastuzumab.

Trastuzumab

Intervention Type: DRUG

Systemic treatment including trastuzumab.

Trastuzumab-treated without toxicity

Patients without toxicity during/after treatment with trastuzumab.

Trastuzumab

Intervention Type: DRUG

Systemic treatment including trastuzumab.

Cisplatin-treated with toxicity

Patients with toxicity during/after treatment with cisplatin.

Cisplatin

Intervention Type: DRUG

Chemotherapy including cisplatin.

Cisplatin-treated without toxicity

Patients without toxicity during/after treatment with cisplatin.

Cisplatin

Intervention Type: DRUG

Chemotherapy including cisplatin.

Bleomycin-treated with toxicity

Patients with toxicity during/after treatment with bleomycin.

Bleomycin

Intervention Type: DRUG

Chemotherapy including bleomycin.

Bleomycin-treated without toxicity

Patients without toxicity during/after treatment with bleomycin.

Bleomycin

Intervention Type: DRUG

Chemotherapy including bleomycin.

Interventions

Anthracyclines

Chemotherapy regimen containing anthracyclines.

Intervention Type: DRUG

Trastuzumab

Systemic treatment including trastuzumab.

Intervention Type: DRUG

Cisplatin

Chemotherapy including cisplatin.

Intervention Type: DRUG

Bleomycin

Chemotherapy including bleomycin.

Intervention Type: DRUG

Eligibility 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.

• 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.

Exclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J.A. Gietema, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

201700454

Identifier Type: -

Identifier Source: org_study_id