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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 : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
J.A. Gietema, University Medical Center Groningen

Tracking Information
First Submitted Date June 22, 2017
First Posted Date June 26, 2017
Last Update Posted Date May 10, 2019
Actual Study Start Date December 12, 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03199300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 22, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating Cardiovascular Adverse Events Related to Cancer Treatment
Official Title Investigating Cardiovascular Adverse Events Related to Cancer Treatment: a Study of Extreme Toxicity Using Induced Pluripotent Stem Cells
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Urine sample, blood sample, germline DNA, skin fibroblasts.
Sampling Method Non-Probability Sample
Study Population Patients treated for a malignancy with any of the described cytotoxic agents.
Condition
  • Toxicity Due to Chemotherapy
  • Cardiovascular Morbidity
  • Cancer, Treatment-Related
Intervention
  • Drug: Anthracyclines
    Chemotherapy regimen containing anthracyclines.
  • Drug: Trastuzumab
    Systemic treatment including trastuzumab.
  • Drug: Cisplatin
    Chemotherapy including cisplatin.
  • Drug: Bleomycin
    Chemotherapy including bleomycin.
Study Groups/Cohorts
  • Anthracylines-treated with toxicity
    Patients with toxicity during/after treatment with anthracylines.
    Intervention: Drug: Anthracyclines
  • Anthracyclines-treated without toxicity
    Patients without toxicity during/after treatment with anthracylines.
    Intervention: Drug: Anthracyclines
  • Trastuzumab-treated with toxicity
    Patients with toxicity during/after treatment with trastuzumab.
    Intervention: Drug: Trastuzumab
  • Trastuzumab-treated without toxicity
    Patients without toxicity during/after treatment with trastuzumab.
    Intervention: Drug: Trastuzumab
  • Cisplatin-treated with toxicity
    Patients with toxicity during/after treatment with cisplatin.
    Intervention: Drug: Cisplatin
  • Cisplatin-treated without toxicity
    Patients without toxicity during/after treatment with cisplatin.
    Intervention: Drug: Cisplatin
  • Bleomycin-treated with toxicity
    Patients with toxicity during/after treatment with bleomycin.
    Intervention: Drug: Bleomycin
  • Bleomycin-treated without toxicity
    Patients without toxicity during/after treatment with bleomycin.
    Intervention: Drug: Bleomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 22, 2017)
48
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2021
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
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.

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03199300
Other Study ID Numbers 201700454
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party J.A. Gietema, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
Investigators
Principal Investigator: J.A. Gietema, MD, PhD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date May 2019