An observational study in Testicular Neoplasms, Spermatic Cord Torsion and Varicocele, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-17.
Sponsored by Rabin Medical Center · Observational
Testicular Cancer is the most prevalent malignancy among men between 20 and 34 years of age, with incidence rates rising in western countries including Israel. Cure rate of testicular cancer exceeds 90% with modern treatments. Thus issues such as quality of life (QoL), coping, effects on couple relationships, cognitive function, cognitive orientation and hormonal function become increasingly important. This study aims to assess all these issues using validated, reproducible questionnaires and hormonal plasma levels, and compare them between testicular cancer survivors and controls.
The study will be conducted in RMC, Beilinson and Golda. Eligible male patient list will be drawn from the Rabin Medical Center (RMC) operation rooms' data system.
Patients will be contacted by their treating urologists over the phone or during follow-up visits and invited to take part in the research which will be conducted at RMC. The first stage of the study will include a validation of the EORTC QLQ-TC26 questionnaire in Hebrew.
Patients and partners / spouses will sign informed-consent forms and fill out questionnaires during their visit, and blood samples will be drawn on the day of questionnaire completion or no longer than 1 month from it. Spouses will be given the choice of arriving with the patient and filling-in their questionnaires at RMC, or having them mailed to their homes. Research assistants will provide assistance with the questionnaires.
Normal controls will be recruited among Tel Aviv University students, 'Achva' College students and RMS staff and asked to come to RMC for blood tests. Control subjects will be asked to answer the same cancer-related questionnaires as the patients, as fully as possible, unless the questions are irrelevant to them.
The anticipated recruitment period will be approximately 36 months. Financial incentives: a compensation of 150 NIS will be offered to healthy participants coming to RMC for blood tests under this study.
Duration of research participation: 1 or 2 encounters (the second for missing data or missing blood samples, and in the first 30 patients - for TC26 questionnaire re-validation by the EORTC requirements), during no longer than 1 month for each participant.
Measurements will be compared across the patient and 2 control groups and their correlation to hormonal function assessed.
295 studies on the registry are indexed under Testicular Neoplasms; 51 are open to participants now.
This study's planned enrollment of 330 is above the median of 133 across 73 observational studies indexed under Testicular Neoplasms.
Browse Testicular Neoplasms studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Group1: Testicular cancer long-term survivors Group 2: Benign testicular conditions patients Group 3: Healthy Controls Partners of males from above 3 groups
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group1: Testicular cancer long-term survivors
Exclusion criteria:
Group1: Testicular cancer long-term survivors
Partners of males from above 3 groups
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated for testicular cancer, will receive questionnaires and hormonal function measurement.
Other: Questionnaires · Other: Hormonal Function measurement
Patients treated for benign testicular conditions, will receive questionnaires and hormonal function measurement.
Other: Questionnaires · Other: Hormonal Function measurement
Healthy volunteers, will receive questionnaires and hormonal function measurement.
Other: Questionnaires · Other: Hormonal Function measurement
Questionnaires: For examinee: European Organization for Research and Treatment of Cancer quality of life questionnaire of 30 items and testicular cancer module of 26 items (EORTC QLQ-30 + QLQ-TC-26), Multidimensional Coping Inventory, The Meaning Test for cognitive function, cognitive orientation questionnaires. For partner: Multidimensional Inventory of quality of life (QoL) for Adults, Multidimensional Coping Inventory.
Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.
Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire.
Time frame: 2-10 years from diagnosis
Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index
Time frame: 2-10 years from diagnosis
cognitive orientation score
Time frame: 2-10 years from diagnosis
multidimensional coping score
Time frame: 2-10 years from diagnosis
cognitive function as measured by the meaning test
Time frame: 2-10 years from diagnosis
Partner's Quality of life, as measured by the multidimensional inventory of QOL for adults questionnaire
Time frame: 2-10 years from diagnosis
Partner's Coping mechanism score, as measured by the Multidimensional Coping Inventory
Time frame: 2-10 years from diagnosis
The record gives a start of Jan 2015, a primary completion of Nov 2018 and a completion of Nov 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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