Testicular NeoplasmsNCT02304575
Quality of Life Among Testicular Cancer Survivors
An observational study of Testicular Neoplasms and Spermatic Cord Torsion, run by Rabin Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Testicular Neoplasms, Spermatic Cord Torsion, Varicocele
- What is being tested?
- Questionnaires and Hormonal Function measurement
- How many people
- 330 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Group1: Testicular cancer long-term survivors Group 2: Benign testicular conditions patients Group 3: Healthy Controls Partners of males from above 3 groups
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
David Margel, MD PhD contact
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center, Beilinson & Hasharon Hospitals
Petah Tikva
David Margel, MD PhD, +972(0)39378089
David Margel, MD Phd
About this study
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.
Read the detailed description
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.
- Being tested
- Questionnaires, Hormonal Function measurement
- Medical subject headings
- Testicular Neoplasms, Spermatic Cord Torsion, Varicocele, Testicular Hydrocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
Hormonal Function measurementOther
Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.
| Study group | Role | What they receive |
|---|---|---|
| Testicular cancer survivors | Patients treated for testicular cancer, will receive questionnaires and hormonal function measurement. Receives: Other: Questionnaires; Other: Hormonal Function measurement | |
| Surgery for benign testicular problems | Patients treated for benign testicular conditions, will receive questionnaires and hormonal function measurement. Receives: Other: Questionnaires; Other: Hormonal Function measurement | |
| Healthy males | Healthy volunteers, will receive questionnaires and hormonal function measurement. Receives: Other: Questionnaires; Other: Hormonal Function measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire.
Measured: 2-10 years from diagnosis
Secondary outcomes (6)
Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index
Measured: 2-10 years from diagnosis
cognitive orientation score
Measured: 2-10 years from diagnosis
multidimensional coping score
Measured: 2-10 years from diagnosis
cognitive function as measured by the meaning test
Measured: 2-10 years from diagnosis
Partner's Quality of life, as measured by the multidimensional inventory of QOL for adults questionnaire
Measured: 2-10 years from diagnosis
Partner's Coping mechanism score, as measured by the Multidimensional Coping Inventory
Measured: 2-10 years from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Margel, MD PhD, Principal investigator, Rabin MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304575
- Sponsor's protocol ID
- 0482-14-RMC
- Status last verified
- Oct 2017
- First submitted
- 27 Nov 2014
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Among Testicular Cancer Survivors
- ClinicalTrials.gov ID
- NCT02304575
- Acronym / sponsor ID
- 0482-14-RMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Testicular cancer survivors | – | Other: Questionnaires, Other: Hormonal Function measurementPatients treated for testicular cancer, will receive questionnaires and hormonal function measurement. |
| Surgery for benign testicular problems | – | Other: Questionnaires, Other: Hormonal Function measurementPatients treated for benign testicular conditions, will receive questionnaires and hormonal function measurement. |
| Healthy males | – | Other: Questionnaires, Other: Hormonal Function measurementHealthy volunteers, will receive questionnaires and hormonal function measurement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group1: Testicular cancer long-term survivors Group 2: Benign testicular conditions patients Group 3: Healthy Controls Partners of males from above 3 groups
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires: 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. | Other | Healthy males, Surgery for benign testicular problems, Testicular cancer survivors |
| Hormonal Function measurementPlasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index. | Other | Healthy males, Surgery for benign testicular problems, Testicular cancer survivors |
Primary outcome
Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire.
Time frame: 2-10 years from diagnosis
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
Related trials for Testicular Neoplasms
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Germ Cell Tumor and Testicular Tumor DNA Registry
Germ Cell Tumor, Testicular Tumor
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Margel, MD PhD contact
David Margel, MD PhD principal investigator
Rabin MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Neoplasms and Spermatic Cord Torsion, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Margel, MD PhD (+972(0)39378089), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire. (time frame: 2-10 years from diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.