Testicular CancerSEARCH-1NCT06620016
Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses.
An observational study of Testicular Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the diagnostic performance of circulating microRNAs in detecting the presence of germ cell cancer in patients with small testicular mass or retroperitoneal post-chemotherapy residual mass and suitable for testis sparing surgery and retroperitoneal lymph node dissection… 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?
- Circulating microRNAs.
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 31 Oct 2027
- How long will I take part?
- 30 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All males >= 18 yo with small testicular mass suitable for testis sparing surgery or post-chemotherapy germ cell residual mass suitable for retroperitoneal lymph node dissection.
Who may be able to join
- Age >= 18 years
- Single testicular lesion, with < 2 cm diameter and < 30 % testicular volume involvement;
- Negative Serum Tumour Markers;
- Suitable for testis sparing surgery;
- Informed consent.
- Age >= 18 years
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- Single/multiple post-chemotherapy retroperitoneal lymph node lesion, with > 1 cm (non seminomatous) / > 3 cm (seminomatous) diameter in patients with previous testicular germ cell primary tumour;
- Negative Serum Tumour Markers;
- Suitable for retroperitoneal lymph node dissection;
- Informed consent.
Who cannot join
- None
- COHORT B:
- None
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 Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola
Bologna, 40138
Eugenio Brunocilla, Prof., 0512142374, eugenio.brunocilla@unibo.it
About this study
Official title: Diagnostic Role of Circulating microRNAs in Small Testicular Masses Suitable for Testis Sparing Surgery and Post-chemotherapy Residual Masses Suitable for Retroperitoneal Lymph Node Dissection.
The purpose of this study is to evaluate the diagnostic performance of circulating microRNAs in detecting the presence of germ cell cancer in patients with small testicular mass or retroperitoneal post-chemotherapy residual mass and suitable for testis sparing surgery and retroperitoneal lymph node dissection, respectively.
- Conditions
- Testicular Cancer
- Being tested
- Circulating microRNAs.
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating microRNAs.Diagnostic test
Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels.
| Study group | Role | What they receive |
|---|---|---|
| A | Small testicular mass suitable for testis sparing surgery. Receives: Diagnostic Test: Circulating microRNAs. | |
| B | Retroperitoneal post-chemotherapy residual mass suitable for retroperitoneal lymph node dissection. Receives: Diagnostic Test: Circulating microRNAs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNA's germ cell cancer detection (Cohort A)
Preoperative circulating microRNA's diagnostic accuracy in detecting germ cell cancer in patients with small testicular mass and submitted to testis sparing surgery, using post-operative surgical specimen as reference.
Measured: Baseline.
MicroRNA's germ cell cancer detection (Cohort B)
Preoperative circulating microRNA's diagnostic accuracy in detecting germ cell cancer in patients with post-chemotherapy residual mass and submitted to retroperitoneal lymph node dissection, using post-operative surgical specimen as reference.
Measured: Baseline.
Secondary outcomes (3)
MicroRNA's germ cell cancer subtype detection (Cohort A + B)
Preoperative circulating microRNA's diagnostic accuracy in detecting seminomatous and non-seminomatous germ cell cancer in patients with small testicular mass/post-chemotherapy residual mass and submitted to testis sparing surgery/retroperitoneal lymph node dissection, using post-operative surgical specimen as reference.
Measured: Baseline.
MicroRNA's vs Frozen Section Examination's germ cell cancer detection (Cohort A)
Comparison between preoperative circulating microRNA and Frozen Section Examination in detecting germ cell cancer in patients with small testicular mass and submitted to testis sparing surgery, using post-operative surgical specimen as reference.
Measured: Baseline.
MicroRNA's disease recurrence/persistence detection (Cohort A + B)
Postoperative circulating microRNA's diagnostic accuracy in detecting disease recurrence/persistence in patients with small testicular mass/post-chemotherapy residual mass and submitted to testis sparing surgery/retroperitoneal lymph node dissection, using post-operative radiological imaging as reference.
Measured: Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (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 Azienda Ospedaliero-Universitaria di BolognaThe 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
- 60 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620016
- Sponsor's protocol ID
- SEARCH-1
- Acronym
- SEARCH-1
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Role of Circulating microRNAs in Small Testicular Masses Suitable for Testis Sparing Surgery and Post-chemotherapy Residual Masses Suitable for Retroperitoneal Lymph Node Dissection.
- ClinicalTrials.gov ID
- NCT06620016
- Acronym / sponsor ID
- SEARCH-1 / SEARCH-1
- Conditions
- Testicular Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 Oct 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 purpose of this study is to evaluate the diagnostic performance of circulating microRNAs in detecting the presence of germ cell cancer in patients with small testicular mass or retroperitoneal post-chemotherapy residual mass and suitable for testis sparing surgery and retroperitoneal lymph node dissection, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Diagnostic Test: Circulating microRNAs.Small testicular mass suitable for testis sparing surgery. |
| B | – | Diagnostic Test: Circulating microRNAs.Retroperitoneal post-chemotherapy residual mass suitable for retroperitoneal lymph node dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All males >= 18 yo with small testicular mass suitable for testis sparing surgery or post-chemotherapy germ cell residual mass suitable for retroperitoneal lymph node dissection.
Key inclusion criteria (10 listed)
- Age >= 18 years
- Single testicular lesion, with < 2 cm diameter and < 30 % testicular volume involvement;
- Negative Serum Tumour Markers;
- Suitable for testis sparing surgery;
- Informed consent.
Key exclusion criteria (3 listed)
- None
- None
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 |
|---|---|---|
| Circulating microRNAs.Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels. | Diagnostic test | A, B |
Primary outcome
MicroRNA's germ cell cancer detection (Cohort A)
Time frame: Baseline.
Preoperative circulating microRNA's diagnostic accuracy in detecting germ cell cancer in patients with small testicular mass and submitted to testis sparing surgery, using post-operative surgical specimen as reference.
MicroRNA's germ cell cancer detection (Cohort B)
Time frame: Baseline.
Preoperative circulating microRNA's diagnostic accuracy in detecting germ cell cancer in patients with post-chemotherapy residual mass and submitted to retroperitoneal lymph node dissection, using post-operative surgical specimen as reference.
3 secondary outcomes
MicroRNA's germ cell cancer subtype detection (Cohort A + B)
Time frame: Baseline.
MicroRNA's vs Frozen Section Examination's germ cell cancer detection (Cohort A)
Time frame: Baseline.
MicroRNA's disease recurrence/persistence detection (Cohort A + B)
Time frame: Week 4.
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 21 Oct 2024.
- Individual participant dataSharing planned: Yes
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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.
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola
Bologna, Italy
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 Azienda Ospedaliero-Universitaria di Bologna 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 10 inclusion and 3 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 21 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MicroRNA's germ cell cancer detection (Cohort A) (time frame: Baseline.). The study lists 2 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 21 Oct 2024.