Testicular CancerNCT06389409
Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients
An observational study of Testicular Cancer, run by IRCCS San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Observation of testicular cancer patients
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 24 Aug 2010to 31 Aug 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: Patients suffering from neoplastic testicular pathology undergoing (or candidates for) surgery
Who may be able to join
- 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
Who cannot join
- subjects < 18 years
- presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Alessia d'Arma, PhD, 02 2643 5506, darma.alessia@hsr.it
About this study
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
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.
Read the 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.
- Conditions
- Testicular Cancer
- Being tested
- Observation of testicular cancer patients
- Keywords
- testicular cancer
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of testicular cancer patientsOther
Collection of clinical data of all patients suffering from neoplastic testicular pathology undergoing surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Observation of testicular cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical data
Collection of clinical data
Measured: Baseline
Adjuvant therapy
Which type of adjuvant therapy carried out (chemotherapy - radiotherapy - retroperitoneal lymphadenectomy)
Measured: Baseline
lactate dehydrogenase
Oncological follow-up through enzymatic value
Measured: Follow up after 6 months from baseline
Testicular objective examination
Number and size (via Prader orchidometer) of the testicles
Measured: Baseline
Testicular objective examination - cysts
Evaluation presence of cysts
Measured: Baseline
Testicular objective examination - nodules
Evaluation presence of nodules
Measured: Baseline
Testicular objective examination - varicocele
Evaluation presence of varicocele
Measured: Baseline
Testicular objective examination - hydrocele
Evaluation presence of hydrocele
Measured: Baseline
α-feto protein
Oncological follow-up through enzymatic value
Measured: Follow up after 6 months from baseline
β human Chorionic Gonadotropin
Oncological follow-up through hormonal value
Measured: Follow up after 6 months from baseline
carcinoembryonic antigen
Oncological follow-up through hormonal value
Measured: Follow up after 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start24 Aug 2010
- Primary completion1 Sep 2030 (estimated)
- Study completion31 Aug 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
- Investigators
- Andrea Salonia, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389409
- Sponsor's protocol ID
- Protocollo N.2009 Testicolo
- Status last verified
- Apr 2024
- First submitted
- 20 Feb 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06389409
- Acronym / sponsor ID
- Protocollo N.2009 Testicolo
- Conditions
- Testicular Cancer
- Keywords
- testicular cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 24 Aug 2010 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 31 Aug 2040 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with testicular cancer | – | Other: Observation of testicular cancer patients* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from neoplastic testicular pathology undergoing (or candidates for) surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- subjects < 18 years
- presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of testicular cancer patientsCollection of clinical data of all patients suffering from neoplastic testicular pathology undergoing surgery | Other | Patient with testicular cancer |
Primary outcome
Clinical data
Time frame: Baseline
Collection of clinical data
Adjuvant therapy
Time frame: Baseline
Which type of adjuvant therapy carried out (chemotherapy - radiotherapy - retroperitoneal lymphadenectomy)
lactate dehydrogenase
Time frame: Follow up after 6 months from baseline
Oncological follow-up through enzymatic value
Testicular objective examination
Time frame: Baseline
Number and size (via Prader orchidometer) of the testicles
Testicular objective examination - cysts
Time frame: Baseline
Evaluation presence of cysts
Testicular objective examination - nodules
Time frame: Baseline
Evaluation presence of nodules
Testicular objective examination - varicocele
Time frame: Baseline
Evaluation presence of varicocele
Testicular objective examination - hydrocele
Time frame: Baseline
Evaluation presence of hydrocele
α-feto protein
Time frame: Follow up after 6 months from baseline
Oncological follow-up through enzymatic value
β human Chorionic Gonadotropin
Time frame: Follow up after 6 months from baseline
Oncological follow-up through hormonal value
carcinoembryonic antigen
Time frame: Follow up after 6 months from baseline
Oncological follow-up through hormonal value
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Salonia, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Salonia, MD (+390226435661, salonia.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical data (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.