Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients

Testicular Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389409
• Other study ID #: Protocollo N.2009 Testicolo
• Status: Recruiting
• Start date: August 24, 2010
• Est. completion date: August 31, 2040

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Andrea Salonia, MD
• Phone: +390226435661
• Email: salonia.andrea[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 31, 2040
• Est. primary completion date: September 1, 2030
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

Intervention

Other:
• Observation of testicular cancer patients
Collection of clinical data of all patients suffering from neoplastic testicular pathology undergoing surgery

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical data	Collection of clinical data	Baseline
Primary	Adjuvant therapy	Which type of adjuvant therapy carried out (chemotherapy - radiotherapy - retroperitoneal lymphadenectomy)	Baseline
Primary	lactate dehydrogenase	Oncological follow-up through enzymatic value	Follow up after 6 months from baseline
Primary	Testicular objective examination	Number and size (via Prader orchidometer) of the testicles	Baseline
Primary	Testicular objective examination - cysts	Evaluation presence of cysts	Baseline
Primary	Testicular objective examination - nodules	Evaluation presence of nodules	Baseline
Primary	Testicular objective examination - varicocele	Evaluation presence of varicocele	Baseline
Primary	Testicular objective examination - hydrocele	Evaluation presence of hydrocele	Baseline
Primary	a-feto protein	Oncological follow-up through enzymatic value	Follow up after 6 months from baseline
Primary	ß human Chorionic Gonadotropin	Oncological follow-up through hormonal value	Follow up after 6 months from baseline
Primary	carcinoembryonic antigen	Oncological follow-up through hormonal value	Follow up after 6 months from baseline