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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Clinical data [Срок оценки: Baseline]
• Adjuvant therapy [Срок оценки: Baseline]
• lactate dehydrogenase [Срок оценки: Follow up after 6 months from baseline]
• Testicular objective examination [Срок оценки: Baseline]
• Testicular objective examination - cysts [Срок оценки: Baseline]
• Testicular objective examination - nodules [Срок оценки: Baseline]
• Testicular objective examination - varicocele [Срок оценки: Baseline]
• Testicular objective examination - hydrocele [Срок оценки: Baseline]
• α-feto protein [Срок оценки: Follow up after 6 months from baseline]
• β human Chorionic Gonadotropin [Срок оценки: Follow up after 6 months from baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• IRCCS Ospedale San Raffaele — Milan

Идентификаторы

NCT: NCT06389409 · Protocollo N.2009 Testicolo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗