Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation of testicular cancer patients.
- Who it may be relevant to
- Registry conditions: Testicular Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Observation of testicular cancer patients
Collection of clinical data of all patients suffering from neoplastic testicular pathology undergoing surgery
Primary outcome measures
- Clinical data [Time frame: Baseline]
- Adjuvant therapy [Time frame: Baseline]
- lactate dehydrogenase [Time frame: Follow up after 6 months from baseline]
- Testicular objective examination [Time frame: Baseline]
- Testicular objective examination - cysts [Time frame: Baseline]
- Testicular objective examination - nodules [Time frame: Baseline]
- Testicular objective examination - varicocele [Time frame: Baseline]
- Testicular objective examination - hydrocele [Time frame: Baseline]
- α-feto protein [Time frame: Follow up after 6 months from baseline]
- β human Chorionic Gonadotropin [Time frame: Follow up after 6 months from baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Identifiers
NCT: NCT06389409 · Protocollo N.2009 Testicolo