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Investigating Cardiovascular Adverse Events Related to Cancer Treatment (InvestiCAT)

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ClinicalTrials.gov Identifier: NCT03199300
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
J.A. Gietema, University Medical Center Groningen

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.

Condition or disease Intervention/treatment
Toxicity Due to Chemotherapy Cardiovascular Morbidity Cancer, Treatment-Related Drug: Anthracyclines Drug: Trastuzumab Drug: Cisplatin Drug: Bleomycin

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Investigating Cardiovascular Adverse Events Related to Cancer Treatment: a Study of Extreme Toxicity Using Induced Pluripotent Stem Cells
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bleomycin

Group/Cohort Intervention/treatment
Anthracylines-treated with toxicity
Patients with toxicity during/after treatment with anthracylines.
Drug: Anthracyclines
Chemotherapy regimen containing anthracyclines.

Anthracyclines-treated without toxicity
Patients without toxicity during/after treatment with anthracylines.
Drug: Anthracyclines
Chemotherapy regimen containing anthracyclines.

Trastuzumab-treated with toxicity
Patients with toxicity during/after treatment with trastuzumab.
Drug: Trastuzumab
Systemic treatment including trastuzumab.

Trastuzumab-treated without toxicity
Patients without toxicity during/after treatment with trastuzumab.
Drug: Trastuzumab
Systemic treatment including trastuzumab.

Cisplatin-treated with toxicity
Patients with toxicity during/after treatment with cisplatin.
Drug: Cisplatin
Chemotherapy including cisplatin.

Cisplatin-treated without toxicity
Patients without toxicity during/after treatment with cisplatin.
Drug: Cisplatin
Chemotherapy including cisplatin.

Bleomycin-treated with toxicity
Patients with toxicity during/after treatment with bleomycin.
Drug: Bleomycin
Chemotherapy including bleomycin.

Bleomycin-treated without toxicity
Patients without toxicity during/after treatment with bleomycin.
Drug: Bleomycin
Chemotherapy including bleomycin.




Primary Outcome Measures :
  1. Comparison between iPSC-derived cells [ Time Frame: 3 years ]
    Comparison between iPSC-derived cells from toxicity cases and controls, for each of the four different agents.


Secondary Outcome Measures :
  1. Correlate the findings from the iPSC-derived cells with the clinical phenotype of cardiovascular toxicity [ Time Frame: 3 years ]
    Correlate the findings from the iPSC-derived cells with the clinical phenotype of (cardiovascular) toxicity, assessed by circulating biomarkers and cardiac or vascular imaging.


Biospecimen Retention:   Samples With DNA
Urine sample, blood sample, germline DNA, skin fibroblasts.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for a malignancy with any of the described cytotoxic agents.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199300


Contacts
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Contact: J.A. Gietema, MD, PhD +31 50 3612821 j.a.gietema@umcg.nl
Contact: L.C. Steggink, MD +31 50 361 2821 l.c.steggink@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: J.A. Gietema, MD, PhD    +31 50 3612821    j.a.gietema@umcg.nl   
Contact: L.C. Steggink, MD    +31 50 3612821    l.c.steggink@umcg.nl   
Principal Investigator: J.A. Gietema, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: J.A. Gietema, MD, PhD University Medical Center Groningen

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Responsible Party: J.A. Gietema, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03199300     History of Changes
Other Study ID Numbers: 201700454
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by J.A. Gietema, University Medical Center Groningen:
bleomycin
cisplatin
trastuzumab
anthracyclines
toxicity

Additional relevant MeSH terms:
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Neoplasms, Second Primary
Neoplasms
Cisplatin
Trastuzumab
Bleomycin
Antineoplastic Agents
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic