MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial

Официальное название

Phase II Trial of Serum Micro RNA-371 in Detecting Active Germ Cell Tumors in Patients With Suspected Regional Disease - (MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial)

Обзор

This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.

Подробное описание

PRIMARY OBJECTIVE:

I. To measure the accuracy of the blood-based biomarker miRNA-371 to predict pre-operatively the presence of active germ cell malignancy.

OUTLINE: This is an observational study.

Patients undergo blood sample collection during screening and throughout the study. Patients whose screening blood samples show elevated miRNA-371 proceed to standard RPLND surgery. Patients whose screening blood samples show normal levels of miRNA-371 undergo standard surveillance followed by standard RPLND surgery at the time of elevated miRNA-371 levels. Patients may also have their medical records reviewed.

Вмешательства

• Другое Clinical Stage I Disease
  Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or standard surveillance. Surveillance will follow until year 5.
• Другое Clinical Stage I with relapse, CSII Disease
  Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or reassessment and then surveillance will follow until year 5.

Первичные конечные точки

• Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy [Срок оценки: Through study completion, up to 5 years]

Вторичные конечные точки (3)

• The 2-year disease-free survival [Срок оценки: Through study completion, up to 5 years]
• Persistence of positive postoperative miRNA as a predictor of relapse at follow-up [Срок оценки: Through study completion, up to 5 years]
• Negative predictive value of negative pre-operative miRNA [Срок оценки: Through study completion, up to 5 years]

Критерии участия

Критерии включения

• Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT)
• Clinical stage of patient is either:

• Stage I pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse or Stage IIA/B pure seminoma
• Stage I NSGCT OR stage I NSGCT with isolated retroperitoneal relapse or Stage IIA/B NSGCT
• For subjects with retroperitoneal lymphadenopathy: no lymph node >3 cm in greatest dimension with no more than 2 nodes enlarged
• Axial abdominal/pelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 3 months of enrollment if stage I patient
• Axial abdominal/pelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 8 weeks of enrollment if stage II patient
• miRNA-371 can be drawn and sent for analysis at time of consent
• Enrollment within 1 year after orchiectomy for stage I patients
• Enrollment at any timepoint after orchiectomy for stage II patients
• Retroperitoneal lymphadenopathy must be within an RPLND template
• Biopsy of lymph node is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with GCT
• Serum Alpha Feto Protein (AFP) <50 ng/ml, β-Human Chorionic Gonadotropin (β-HCG) 25 mIU/ml within 42 days (6 weeks) of enrollment
• Age ≥ 18 years
• Ability to understand and the willingness to sign a written informed consent

Критерии исключения

• Second primary malignancy
• Patients receiving any other investigational agent (s)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 5 центров

• University of Alabama at Birmingham Cancer Center — Birmingham
• Loma Linda University Medical Center — Loma Linda
• Los Angeles County-USC Medical Center — Los Angeles
• USC / Norris Comprehensive Cancer Center — Los Angeles
• Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center — New Brunswick

Идентификаторы

NCT: NCT06060873 · 4T-22-2 · NCI-2023-00412 · 4T-22-2 · P30CA014089

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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