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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02304575 |
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Date of registration:
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27/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Quality of Life Among Testicular Cancer Survivors
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Scientific title:
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Quality of Life Among Testicular Cancer Survivors |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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330 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02304575 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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David Margel, MD PhD |
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Address:
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Telephone:
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+972(0)39378089 |
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Email:
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Affiliation:
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Name:
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David Margel, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rabin MC |
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Name:
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David Margel, MD PhD |
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Address:
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Telephone:
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+972(0)39378089 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Group1: Testicular cancer long-term survivors
- Male subjects between 2 to 10 years after testicular cancer diagnosis, who have
completed treatment and are regarded as complete responders.
- Able to give informed consent Group 2: Benign testicular conditions patients
- Male subjects between 2 to 10 years after testicular surgery due to a benign
condition.
- Able to give informed consent Group 3: Healthy Controls
- Healthy males
- Able to give informed consent Partners of males from above 3 groups
- Females or males
- In a couple relationship with a man of 1 of the above groups, for 1 year or longer.
- Able to give informed consent
Exclusion criteria:
Group1: Testicular cancer long-term survivors
- Inability to answer questionnaires (i.e due to mental impairment).
- Another malignancy, other than non-invasive skin basal cell carcinoma (BCC) or
squamous cell carcinoma (SCC).
- Testicular cancer recurrence. Group 2: Benign testicular conditions patients
- Inability to answer questionnaires.
- Any history of malignancy other than non-invasive skin BCC or SCC. Group 3: Healthy
Controls
- Inability to answer questionnaires.
- Any history of malignancy other than non-invasive skin BCC or SCC.
- Any history of testicular surgery or diagnosed testicular problems in adulthood or
childhood.
Partners of males from above 3 groups
- Inability to answer questionnaires.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Spermatic Cord Torsion
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Testicular Neoplasms
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Testicular Hydrocele
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Varicocele
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Intervention(s)
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Other: Questionnaires
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Other: Hormonal Function measurement
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Primary Outcome(s)
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Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire.
[Time Frame: 2-10 years from diagnosis]
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Secondary Outcome(s)
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cognitive function as measured by the meaning test
[Time Frame: 2-10 years from diagnosis]
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multidimensional coping score
[Time Frame: 2-10 years from diagnosis]
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Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index
[Time Frame: 2-10 years from diagnosis]
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cognitive orientation score
[Time Frame: 2-10 years from diagnosis]
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Partner's Coping mechanism score, as measured by the Multidimensional Coping Inventory
[Time Frame: 2-10 years from diagnosis]
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Partner's Quality of life, as measured by the multidimensional inventory of QOL for adults questionnaire
[Time Frame: 2-10 years from diagnosis]
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Secondary ID(s)
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0482-14-RMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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