Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses.

NCT ID: NCT06620016

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Testicular Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Small testicular mass suitable for testis sparing surgery.

Circulating microRNAs.

Intervention Type DIAGNOSTIC_TEST

Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels.

B

Retroperitoneal post-chemotherapy residual mass suitable for retroperitoneal lymph node dissection.

Circulating microRNAs.

Intervention Type DIAGNOSTIC_TEST

Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels.

Interventions

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Circulating microRNAs.

Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.


* 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

COHORT B:


* None
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Eugenio Brunocilla, Prof.

Role: primary

0512142374

Other Identifiers

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SEARCH-1

Identifier Type: -

Identifier Source: org_study_id

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