Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses. (SEARCH-1)

October 18, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

COHORT A:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None

COHORT B:

Inclusion Criteria:

  • Age >= 18 years
  • 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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Small testicular mass suitable for testis sparing surgery.
Diagnostic test: Circulating microRNAs.
Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels.
B
Retroperitoneal post-chemotherapy residual mass suitable for retroperitoneal lymph node dissection.
Diagnostic test: Circulating microRNAs.
Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline.
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.
Baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MicroRNA's germ cell cancer subtype detection (Cohort A + B)
Time Frame: Baseline.
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.
Baseline.
MicroRNA's vs Frozen Section Examination's germ cell cancer detection (Cohort A)
Time Frame: Baseline.
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.
Baseline.
MicroRNA's disease recurrence/persistence detection (Cohort A + B)
Time Frame: Week 4.
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.
Week 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEARCH-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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