Clinical trial NCT06389409: Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Testicular Cancer
Keywords: testicular cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 3000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from neoplastic testicular pathology undergoing (or candidates for) surgery

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical data
timeFrame: Baseline
measure: Adjuvant therapy
timeFrame: Baseline
measure: lactate dehydrogenase
timeFrame: Follow up after 6 months from baseline
measure: Testicular objective examination
timeFrame: Baseline
measure: Testicular objective examination - cysts
timeFrame: Baseline
measure: Testicular objective examination - nodules
timeFrame: Baseline
measure: Testicular objective examination - varicocele
timeFrame: Baseline
measure: Testicular objective examination - hydrocele
timeFrame: Baseline
measure: α-feto protein
timeFrame: Follow up after 6 months from baseline
measure: β human Chorionic Gonadotropin
timeFrame: Follow up after 6 months from baseline
measure: carcinoembryonic antigen
timeFrame: Follow up after 6 months from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Andrea Salonia, MD
role: PRINCIPAL_INVESTIGATOR
References: