NCT06389409

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
175mo left

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Aug 2010Aug 2040

Study Start

First participant enrolled

August 24, 2010

Completed
13.5 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2040

Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

20 years

First QC Date

February 20, 2024

Last Update Submit

April 26, 2024

Conditions

Keywords

testicular cancer

Outcome Measures

Primary Outcomes (11)

  • Clinical data

    Collection of clinical data

    Baseline

  • Adjuvant therapy

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

    Baseline

  • lactate dehydrogenase

    Oncological follow-up through enzymatic value

    Follow up after 6 months from baseline

  • Testicular objective examination

    Number and size (via Prader orchidometer) of the testicles

    Baseline

  • Testicular objective examination - cysts

    Evaluation presence of cysts

    Baseline

  • Testicular objective examination - nodules

    Evaluation presence of nodules

    Baseline

  • Testicular objective examination - varicocele

    Evaluation presence of varicocele

    Baseline

  • Testicular objective examination - hydrocele

    Evaluation presence of hydrocele

    Baseline

  • α-feto protein

    Oncological follow-up through enzymatic value

    Follow up after 6 months from baseline

  • β human Chorionic Gonadotropin

    Oncological follow-up through hormonal value

    Follow up after 6 months from baseline

  • carcinoembryonic antigen

    Oncological follow-up through hormonal value

    Follow up after 6 months from baseline

Study Arms (1)

Patient with testicular cancer

* 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

Other: Observation of testicular cancer patients

Interventions

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

Patient with testicular cancer

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from neoplastic testicular pathology undergoing (or candidates for) surgery

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Study Officials

  • Andrea Salonia, MD

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Salonia, MD

CONTACT

Alessia d'Arma, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 20, 2024

First Posted

April 29, 2024

Study Start

August 24, 2010

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

August 31, 2040

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations