Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients
Observational Study on the Quality of Life and Functional/Oncological Outcome of Patients Undergoing Surgery for Testicular Removal and/or Removal of Retro-peritoneal Lymph Nodes
1 other identifier
observational
3,000
1 country
1
Brief Summary
The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition. From this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2010
CompletedFirst Submitted
Initial submission to the registry
February 20, 2024
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2040
April 29, 2024
April 1, 2024
20 years
February 20, 2024
April 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Clinical data
Collection of clinical data
Baseline
Adjuvant therapy
Which type of adjuvant therapy carried out (chemotherapy - radiotherapy - retroperitoneal lymphadenectomy)
Baseline
lactate dehydrogenase
Oncological follow-up through enzymatic value
Follow up after 6 months from baseline
Testicular objective examination
Number and size (via Prader orchidometer) of the testicles
Baseline
Testicular objective examination - cysts
Evaluation presence of cysts
Baseline
Testicular objective examination - nodules
Evaluation presence of nodules
Baseline
Testicular objective examination - varicocele
Evaluation presence of varicocele
Baseline
Testicular objective examination - hydrocele
Evaluation presence of hydrocele
Baseline
α-feto protein
Oncological follow-up through enzymatic value
Follow up after 6 months from baseline
β human Chorionic Gonadotropin
Oncological follow-up through hormonal value
Follow up after 6 months from baseline
carcinoembryonic antigen
Oncological follow-up through hormonal value
Follow up after 6 months from baseline
Study Arms (1)
Patient with testicular cancer
* subjects suffering from suspected neoplastic testicular pathology candidates for testicle removal surgery * patients suffering from neoplastic testicular pathology requiring removal of the retroperitoneal lymph nodes
Interventions
Collection of clinical data of all patients suffering from neoplastic testicular pathology undergoing surgery
Eligibility Criteria
Patients suffering from neoplastic testicular pathology undergoing (or candidates for) surgery
You may qualify if:
- subjects suffering from suspected neoplastic testicular pathology candidates for testicle removal surgery
- patients suffering from neoplastic testicular pathology requiring removal of the retroperitoneal lymph nodes
- subjects \> 18 years old
- subjects with at least elementary education
- signature of informed consent
You may not qualify if:
- subjects \< 18 years
- presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Salonia, MD
IRCCS Ospedale San Raffaele
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 20, 2024
First Posted
April 29, 2024
Study Start
August 24, 2010
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
August 31, 2040
Last Updated
April 29, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share