A Prospective Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumors

Официальное название

A Prospective Observational Cohort Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumor

Обзор

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.

Подробное описание

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:

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.

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.

Первичные конечные точки

• Misure of the level of miRNA37 in plasma samples [Срок оценки: 48 months]
• Presence/absence of malignant cells detected by miRNA371 [Срок оценки: 48 months]

Вторичные конечные точки (4)

• Relapse on Surveillance [Срок оценки: 48 months]
• Relapse on Treatment [Срок оценки: 48 months]
• Relapse Free Survival [Срок оценки: 48 months]
• Overall Survival [Срок оценки: 48 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Fondazione del Piemonte per l'Oncologia — Candiolo

Идентификаторы

NCT: NCT07453082 · 023-FPO21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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