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Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study) (STANDBY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572934
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
J.A. Gietema, University Medical Center Groningen

Brief Summary:
Depending on disease stage, testicular cancer (TC) treatment consists of an orchidectomy, alone or followed by radiotherapy (RT) or platinum-based chemotherapy (CT). TC survival rates are above 90% nowadays, which results in growing TC survivor population. Because of the long life expectancy of these survivors, prevention or early detection of late treatment effects has become increasingly relevant. Yet known late effects are nephrotoxicity, cardiovascular disease (CVD), secondary malignant neoplasms (SMN), neurotoxicity, pulmonary toxicity, Raynaud's phenomenon, hypogonadism, fatigue and psychosocial problems. Nephrotoxicity is an important late effect, but data is lacking in very long-term survivors since performed studies have a follow-up duration of 5-14 years. Decreased renal function is a known risk factor for CVD development and also an association between renal function and neurtoxicity via circulating platinum levels has been shown. It is hypothesized that treatment induced nephrotoxicity is prevalent in TC survivors and might be a mediator for development of late effects. The secondary aim is to assess prevalence of late effects in very long-term TC survivors: until now, most data have been collected through questionnaires in large epidemiological studies in TC survivors till approximately 10 years after treatment. The prevalence of late effects may increase over time: 10 years after treatment late effects may not be present yet, whilst late effects can emerge just after 20 years. Consequently, health status and possible late effects, resulting in morbidity, are underestimated in patients who are 20-30 years after treatment. By investigating health status of these very long-term survivors a more profound insight in the prevalence and aetiology of these late effects and the development over time can be assessed. Current treatment is very similar to TC treatment 20-30 years ago and therefore knowledge on late effects is relevant for currently treated patients. Furthermore, as a result of this study, we will better understand which factors and issues should be watched closely during follow-up, which TC survivors are at increased risk of developing late treatment effects and how to detect early damage before overt morbidity occurs.

Condition or disease
Testicular Cancer

Detailed Description:

Objective: The aim of this study is to compare glomerular filtration rate (GFR) in very long-term testicular cancer (TC)-survivors treated with chemotherapy, radiotherapy or surgery only and non-cancer treated healthy controls. Secondary aim is to assess prevalence of adverse late treatment effects in very long-term TC-survivors treated with chemotherapy (CT), radiotherapy (RT) or surgery only (SU) and investigate the relationship between GFR parameters and these late effects.

Study population: Patients treated with CT, RT or only surgery for TC more than 20 years ago and an age-matched male control population.

Study design: An observational cross-sectional cohort study will be performed. Patients will be invited for a single study visit, which consists of collection of urine during 24 hours, withdrawal of blood samples, filling in questionnaires, physical examination, vascular function and structure tests, lung function tests, digital cooling tests, neuropsychological assessment and a walk test.

Main study parameters/endpoints: Primary study parameter is renal function as expressed by glomerular filtration rate (GFR). Secondary endpoints are the prevalence of the following defined adverse late effects: cardiovascular disease (CVD), peripheral neuropathy, reduced lung function, Raynaud's phenomenon, hypogonadism, fatigue and cognitive dysfunction. Other secondary parameters are health related quality of life (HRQoL), physical fitness, markers for (subclinical) vascular damage, single nucleotide polymorphisms (SNPs) and aging markers.

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Study Type : Observational
Actual Enrollment : 281 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)
Actual Study Start Date : August 2015
Actual Primary Completion Date : January 10, 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Chemotherapy group (CT-group)
Patients treated with chemotherapy >20 years ago
Radiotherapy group (RT-group)
Patients treated with radiotherapy >20 years ago
Surgery-only group (SU-group)
Patients treated with only orchidectomy >20 years ago
Control-group
Healthy controls



Primary Outcome Measures :
  1. Glomerular filtration rate (GFR) in ml/min [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Development of cardiovascular disease (CVD) according to the WHO ICD-10 classification (I10-I15: hypertensive disease; I20-I25: ischemic heart disease; I60-I69: cerebrovascular disease; I70-I79: disease of arteries, arterioles and capillaries) [ Time Frame: 3 years ]
  2. Peripheral neuropathy (anamnestic with SCIN questionnaire which assesses a.o. chemotherapy-induced peripheral sensory neuropathy) [ Time Frame: 3 years ]
  3. Raynaud's phenomenon (anamnestic with SCIN questionnaire which assesses a.o. Raynaud's phenomenon and objectified with standardized digital cooling tests) [ Time Frame: 3 years ]
  4. Lung function (FEV1, FVC, TLC, RV, FRC and diffusion capacity (DLCO, KCO)) [ Time Frame: 3 years ]
  5. Hypogonadism (LH > 10 U/l or testosterone < 14 ng/ml) [ Time Frame: 3 years ]
  6. Cognitive function (neuropsychological assessment of different domains: learning, memory, processing speed, executive function) [ Time Frame: 3 years ]
  7. Fatigue (scaled; VVV-questionnaire) [ Time Frame: 3 years ]
  8. Testicular cancer disease characteristics: stage, prognosis group, chemotherapy regimen/dose, radiotherapy doses/location [ Time Frame: 3 years ]
  9. Health-related quality of life (HRQoL) [ Time Frame: 3 years ]
  10. Physical fitness (according to six-minute walk test with sex, age and BMI specific reference values) [ Time Frame: 3 years ]
  11. Intima media thickness (IMT) [ Time Frame: 3 years ]
  12. Advanced Glycation End products (AGEs) [ Time Frame: 3 years ]
  13. Cardiovascular risk factors (presence of hypertension, dyslipidemia, impaired fasting glucose, overweight/obesity, tobacco and alcohol use, family history) [ Time Frame: 3 years ]
  14. Genetic susceptibility for (cardio)vascular damage (single nucleotide polymorphisms (SNPs) in DNA) [ Time Frame: 3 years ]
  15. Leukocyte telomere length [ Time Frame: 3 years ]
  16. Arterial stiffness measured as pulse-wave velocity (PWV) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Potential participating TC survivors will be identified by the TC registry of the uro-oncology tumor working group of the UMCG. The investigators will randomly select (with an SPSS-query) 70 potential participants from the CT-group and search for age-matched controls in the RT-, SU- and CO-group. A margin of three years will be accepted. If no matching RT-patients, SU-patients or healthy volunteers are available, age-matching criteria will be relaxed by allowing the difference to increase with one year at each step, to a maximum of six years. Vital status will be checked with help of information from the municipal population registry (GBA:'gemeentelijke basisadministratie'). Healthy volunteers are recruited via advertisements in local door-to-door papers and by flyers exposed in the UMCG.
Criteria

Inclusion Criteria:

  1. Age <70 years at time of inclusion
  2. Signed informed consent
  3. CT-, RT- and SU-group: Age at start of TC treatment <40 yrs.
  4. CT-, RT- and SU-group: At least 20 years after start of treatment for TC at time of inclusion.
  5. CT-group: Patients treated with cisplatin-based chemotherapy for TC with good or intermediate prognosis (according to IGCCCG prognosis group).
  6. RT-group: Patients treated with radiotherapy for TC stage I or II.
  7. SU-group: Patients treated with orchidectomy only for TC stage I.

Exclusion Criteria:

  1. Mental disorder (no informed consent available).
  2. CT-group: Patients also treated with radiotherapy for TC.
  3. RT-group: Patients also treated with chemotherapy for TC.
  4. SU-group: Patients also treated with chemo- or radiotherapy for TC.
  5. CO-group: Treated with chemotherapy, radiotherapy or hormonal therapy for any type of cancer.

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): NCT02572934


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Jourik Gietema, MD PhD Universirty Medical Centre Groningen
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Responsible Party: J.A. Gietema, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02572934    
Other Study ID Numbers: NL53126.042.15
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by J.A. Gietema, University Medical Center Groningen:
Testicular cancer
Survivorship
late adverse treatment effects
Additional relevant MeSH terms:
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Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders