Actively Recruiting
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
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-10-21
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of circulating microRNAs to detect germ cell cancer in men with small testicular masses or residual tumors after chemotherapy. The study focuses on patients suitable for testis sparing surgery or retroperitoneal lymph node dissection. This observational study aims to improve diagnosis by comparing microRNA levels to traditional methods. Participants are divided into two groups: those with small testicular lesions less than 2 cm and less than 30% testicular volume involvement, and those with post-chemotherapy retroperitoneal lymph node lesions greater than 1 cm for non-seminomatous or greater than 3 cm for seminomatous types. Blood samples will be taken before and after surgery to measure circulating microRNAs. The study includes evaluation at baseline and at four weeks to detect cancer presence, subtype, and any recurrence or persistence. During the study, participants will undergo blood tests to measure microRNA levels alongside other diagnostic procedures. Researchers will compare microRNA detection with frozen section examination results in the first group. The study assesses the accuracy of microRNAs in identifying germ cell cancer and monitors disease status over time. Participants' involvement is based on scheduled assessments, with informed consent and follow-up at four weeks post-surgery.
CONDITIONS
Brief Title
Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For Cohort A: Single testicular lesion less than 2 cm in diameter and involving less than 30% of testicular volume
- For Cohort A: Negative serum tumor markers
- For Cohort A: Suitable for testis sparing surgery
- For Cohort A: Informed consent
- For Cohort B: Single or multiple post-chemotherapy retroperitoneal lymph node lesion larger than 1 cm (non-seminomatous) or larger than 3 cm (seminomatous) in patients with prior testicular germ cell tumor
- For Cohort B: Negative serum tumor markers
- For Cohort B: Suitable for retroperitoneal lymph node dissection
- For Cohort B: Informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo pre-surgery evaluation of peripheral blood circulating microRNAs levels to detect germ cell cancer and its subtypes.
1 visit (in-person)
Duration - 4 weeks after surgery
Participants undergo post-surgery evaluation of peripheral blood circulating microRNAs levels to detect disease recurrence or persistence.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola
Bologna, Italy, 40138
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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