NCT02304575

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

November 27, 2014

Last Update Submit

October 15, 2017

Conditions

Testicular NeoplasmsSpermatic Cord TorsionVaricoceleTesticular Hydrocele

Outcome Measures

Primary Outcomes (1)

  • Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire.

    2-10 years from diagnosis

Secondary Outcomes (6)

  • Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index

    2-10 years from diagnosis

  • cognitive orientation score

    2-10 years from diagnosis

  • multidimensional coping score

    2-10 years from diagnosis

  • cognitive function as measured by the meaning test

    2-10 years from diagnosis

  • Partner's Quality of life, as measured by the multidimensional inventory of QOL for adults questionnaire

    2-10 years from diagnosis

  • +1 more secondary outcomes

Study Arms (3)

Testicular cancer survivors

Patients treated for testicular cancer, will receive questionnaires and hormonal function measurement.

Other: QuestionnairesOther: Hormonal Function measurement

Surgery for benign testicular problems

Patients treated for benign testicular conditions, will receive questionnaires and hormonal function measurement.

Other: QuestionnairesOther: Hormonal Function measurement

Healthy males

Healthy volunteers, will receive questionnaires and hormonal function measurement.

Other: QuestionnairesOther: Hormonal Function measurement

Interventions

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.

Healthy malesSurgery for benign testicular problemsTesticular cancer survivors
Hormonal Function measurementOTHER

Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.

Healthy malesSurgery for benign testicular problemsTesticular cancer survivors

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson & Hasharon Hospitals

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Testicular NeoplasmsSpermatic Cord TorsionVaricoceleTesticular Hydrocele

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David Margel, MD PhD

    Rabin MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Margel, MD PhD

CONTACT

+972(0)39378089

Chen G Shenhar, MD

CONTACT

+972(0)546301847g.shenhar@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 2, 2014

Study Start

January 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations

IL(1)