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NCT Number: NCT06389409

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

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.

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Key information

Conditions

Testicular Cancer Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location status: Recruiting

Location contact

Alessia d'Arma, PhD

CONTACT

[email protected]

02 2643 5506

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation of testicular cancer patients

Other

Collection of clinical data of all patients suffering from neoplastic testicular pathology undergoing surgery

Primary outcomes

  1. Clinical data

    Time frame: Baseline

    Collection of clinical data

  2. Adjuvant therapy

    Time frame: Baseline

    Which type of adjuvant therapy carried out (chemotherapy - radiotherapy - retroperitoneal lymphadenectomy)

  3. lactate dehydrogenase

    Time frame: Follow up after 6 months from baseline

    Oncological follow-up through enzymatic value

  4. Testicular objective examination

    Time frame: Baseline

    Number and size (via Prader orchidometer) of the testicles

  5. Testicular objective examination - cysts

    Time frame: Baseline

    Evaluation presence of cysts

  6. Testicular objective examination - nodules

    Time frame: Baseline

    Evaluation presence of nodules

  7. Testicular objective examination - varicocele

    Time frame: Baseline

    Evaluation presence of varicocele

  8. Testicular objective examination - hydrocele

    Time frame: Baseline

    Evaluation presence of hydrocele

  9. α-feto protein

    Time frame: Follow up after 6 months from baseline

    Oncological follow-up through enzymatic value

  10. β human Chorionic Gonadotropin

    Time frame: Follow up after 6 months from baseline

    Oncological follow-up through hormonal value

  11. carcinoembryonic antigen

    Time frame: Follow up after 6 months from baseline

    Oncological follow-up through hormonal value

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia d'Arma, PhD

CONTACT

[email protected]

02 2643 5506

Andrea Salonia, MD

CONTACT

[email protected]

+390226435661

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2030
Study completion
2040
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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