Testicular Germ Cell TumorBRIDGENCT07453082
A Prospective Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumors
An observational study of Testicular Germ Cell Tumor, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial summary
This is a observational study aimed at evaluating miRNA 371a-3p (miRNA 371) as a specific marker for presence or absence of clinically detectable viable germ cell malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Germ Cell Tumor
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 31 Dec 2026
- 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: Patients with newly diagnosed testicular germ cell cancers with: 1. Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy). Patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements. 2. Moderate risk of relapse (26-50% chance of recurrence). Patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.
Who may be able to join
- Patients must be ≥ 18 years of age.
- Patients must have a new diagnosis of a germ cell tumor confirmed pathologically or serologically (diagnostic elevation of HCG/AFP). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible.
- If surgery is planned, male patients with Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration.
- Patients must have risk of relapse assessment determined by the local investigator prior to registration.
- Patients must have initial imaging, laboratory and other clinical evaluations (see below) performed within 42 days prior to registration. Imaging reports, pathology reports and performance status will be collected.
- Patients must have beta-human chorionic gonadotropin (beta-HCG), alpha- fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments within 42 days prior to registration.
- Patients must agree to provide informed consent and required blood specimens for the duration of the study.
Who cannot join
- Patients with high risk of relapse or metastatic disease.
- Patients with tumour assessments beyond the time frame required by the protocol.
- Patients not complaint with the protocol schedule.
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
Fondazione del Piemonte per l'Oncologia
Candiolo, Turin, 10060
Pasquale Rescigno, MD, +390119933601, pasquale.rescigno@ircc.it
Ilaria Buondonno, PhD, +390119933393, ilaria.buondonno@ircc.it
About this study
Official title: A Prospective Observational Cohort Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumor
This is a observational study aimed at evaluating miRNA 371a-3p (miRNA 371) as a specific marker for presence or absence of clinically detectable viable germ cell malignancy.
Read the detailed description
This is a observational cohort study to evaluate miRNA 371 in male patients with history of germ cell tumor or newly diagnosed germ cell tumor.
Patients with newly diagnosed testicular germ cell cancers will be stratified in:
- Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy). Patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements.
- Moderate risk of relapse (26-50% chance of recurrence). Patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.
The BRIDGE study evaluate the plasma expression of miRNA 371 as biomarker of relapse and its ability to detect germ cell malignancy within each of the early stage testicular seminoma and nonseminoma groups.
- Conditions
- Testicular Germ Cell Tumor
- Medical subject headings
- Testicular Germ Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low risk of relapse | Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy): patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements. | |
| Moderate risk of relapse | Moderate risk of relapse (26-50% chance of recurrence): patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Misure of the level of miRNA37 in plasma samples
The study will prospectively collect samples and performed scans to evaluate the ability of miRNA371 in detecting (or anticipate) disease progression.
Measured: 48 months
Presence/absence of malignant cells detected by miRNA371
The study will validate the capacity of miRNA371 to assess the presence of viable malignant cells otherwise not visible with standard imaging.
Measured: 48 months
Secondary outcomes (4)
Relapse on Surveillance
Evidence of unequivocal clinically or pathologically confirmed recurrent germ cell tumor on surveillance
Measured: 48 months
Relapse on Treatment
Evidence of unequivocal clinically or pathologically confirmed germ cell tumor during or after specific treatment for germ cell tumor including chemotherapy, radiation therapy or surgery
Measured: 48 months
Relapse Free Survival
Relapse free survival is measured from the date of orchiectomy until the date of first observation of relapse on surveillance, or from the date of achieving complete remission until the date of first observation of relapse on treatment, or death due to any cause. Patients last known to be alive and without report of relapse are censored at date of last contact
Measured: 48 months
Overall Survival
Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Jul 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular Germ Cell TumorStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pasquale Rescigno, MD, Principal investigator, Fondazione del Piemonte per l'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453082
- Sponsor's protocol ID
- 023-FPO21
- Acronym
- BRIDGE
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumor
- ClinicalTrials.gov ID
- NCT07453082
- Acronym / sponsor ID
- BRIDGE / 023-FPO21
- Conditions
- Testicular Germ Cell Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Mar 2026 (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.
This is a observational study aimed at evaluating miRNA 371a-3p (miRNA 371) as a specific marker for presence or absence of clinically detectable viable germ cell malignancy.
Detailed description
This is a observational cohort study to evaluate miRNA 371 in male patients with history of germ cell tumor or newly diagnosed germ cell tumor.
Patients with newly diagnosed testicular germ cell cancers will be stratified in:
- Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy). Patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements.
- Moderate risk of relapse (26-50% chance of recurrence). Patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.
The BRIDGE study evaluate the plasma expression of miRNA 371 as biomarker of relapse and its ability to detect germ cell malignancy within each of the early stage testicular seminoma and nonseminoma groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low risk of relapse | – | –Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy): patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements. |
| Moderate risk of relapse | – | –Moderate risk of relapse (26-50% chance of recurrence): patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed testicular germ cell cancers with: 1. Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy). Patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements. 2. Moderate risk of relapse (26-50% chance of recurrence). Patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.
Key inclusion criteria (7 listed)
- Patients must be ≥ 18 years of age.
- Patients must have a new diagnosis of a germ cell tumor confirmed pathologically or serologically (diagnostic elevation of HCG/AFP). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible.
- If surgery is planned, male patients with Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration.
- Patients must have risk of relapse assessment determined by the local investigator prior to registration.
- Patients must have initial imaging, laboratory and other clinical evaluations (see below) performed within 42 days prior to registration. Imaging reports, pathology reports and performance status will be collected.
Key exclusion criteria (3 listed)
- Patients with high risk of relapse or metastatic disease.
- Patients with tumour assessments beyond the time frame required by the protocol.
- Patients not complaint with the protocol schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Misure of the level of miRNA37 in plasma samples
Time frame: 48 months
The study will prospectively collect samples and performed scans to evaluate the ability of miRNA371 in detecting (or anticipate) disease progression.
Presence/absence of malignant cells detected by miRNA371
Time frame: 48 months
The study will validate the capacity of miRNA371 to assess the presence of viable malignant cells otherwise not visible with standard imaging.
4 secondary outcomes
Relapse on Surveillance
Time frame: 48 months
Relapse on Treatment
Time frame: 48 months
Relapse Free Survival
Time frame: 48 months
Overall Survival
Time frame: 48 months
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 5 Mar 2026.
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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.
Pasquale Rescigno, MD principal investigator
Fondazione del Piemonte per l'Oncologia
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 Germ Cell Tumor, run by Fondazione del Piemonte per l'Oncologia 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 7 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 5 Mar 2026. 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 Pasquale Rescigno, MD (+390119933601, pasquale.rescigno@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Misure of the level of miRNA37 in plasma samples (time frame: 48 months). 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 5 Mar 2026.