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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06389409
Other study ID # Protocollo N.2009 Testicolo
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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