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NCT Number: NCT06620016

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

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.

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Key information

Conditions

Testicular Cancer Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

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

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Eugenio Brunocilla, Prof.

CONTACT

[email protected]

0512142374

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circulating microRNAs.

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study 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.

Acronym: SEARCH-1

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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