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

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.

Study Overview

• Status: Recruiting
• Conditions: Testicular Cancer
• Intervention / Treatment: Other: Observation of testicular cancer patients

Detailed Description

Testicular cancer constitutes 1% to 1.5% of male tumors, 5% of urological tumors. In the Western society to which we belong, the incidence is between 3 and 6 new cases per 100,000 inhabitants per year. In particular, this incidence has recorded continuous growth over the last thirty years. Different histologies of this disease are known, with a clear prevalence of germ cell tumors (90-95%).

From these general epidemiological coordinates it can be deduced that this pathology could affects a young segment of the population; It must be underlined that a pathology is peculiar due to the impact it has on the affected individual, who must be treated not only from an oncological point of view but also with regards to the sexual, reproductive and psychological-relational aspects. Such complexity requires a systematic and detailed approach to examine all aspects.

The creation of this database let to have a follow up above all an extension over time that is not present in the literature, especially towards the functional aspects of this condition.

The database will represent a resource for future research.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Andrea Salonia, MD; Phone Number: +390226435661; Email: salonia.andrea@hsr.it
• Study Contact Backup: Name: Alessia d'Arma, PhD; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: Alessia d'Arma, PhD; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from neoplastic testicular pathology undergoing (or candidates for) surgery

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• subjects < 18 years
• presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Observation of testicular cancer patients; Collection of clinical data of all patients suffering from neoplastic testicular pathology undergoing surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Andrea Salonia, MD, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2010
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): August 31, 2040

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: testicular cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Testicular Neoplasms
• Other Study ID Numbers: Protocollo N.2009 Testicolo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No