miRNA to Guide Appropriate Intervention of Small Testis Masses (miRSTM)
miRNA as a Liquid Biomarker to Guide Early Detection and Appropriate Intervention of Incidentally Detected Small Testicular Masses
This study aims to determine, for the first time, if miRNA-371a-3p can be used as an accurate biomarker to identify which small (≤ 2cm) testicular masses are malignant and aid in clinical decision-making to offer surgery or surveillance. We propose a retrospective exploration of banked serum, plasma and semen specimens of men with small testis masses and a prospective biomarker-based intervention trial to validate miR-371a-3p performance.
調査の概要
状態
条件
詳細な説明
Study Intervention:
Blinded measurement of miRNA expression in blood and/or seminal plasma after the decision of treatment choice has been made. Participants will undergo usual clinical care and follow a program of surveillance or surgical removal based on a clinician and patient shared decision.
Primary Objective: To determine if surveillance can be offered as a biomarker-based strategy to patients with solitary small testicular masses (STMs) ≤ 2cm.
Secondary Objectives: 1)To assess the performance characteristics of serum, plasma, and seminal plasma miRNA in a prospectively collected cohort of patients presenting with solitary masses small testicular masses ≤ 2cm.
2)To determine the association between miRNA and the presence of testicular cancer in radical or partial orchiectomy surgical specimens.
3)To evaluate surveillance as a treatment strategy in patients with STMs, negative serum tumour markers and negative miRNA secretion, assessing treatment-free survival (TFS) and metastasis free survival (MFS).
4)Refining analytic methods in miRNA assessment by inter-lab comparison, determining best practices and optimal cut-offs to develop a CLIA-approved assay.
5)To establish an optimal threshold for considering an incidentally found testis mass as a small testicular mass.
Endpoints of the study:
- Treatment free survival (TFS) for those on surveillance
- Metastasis free survival (MFS)
- Expression of miRNA in serum/plasma and/or seminal plasma in patients with STMs
- Correlation between secretion of miRNA in STMs and GCTs or GCNIS identified in subsequent pathologic examination of surgical specimens or biopsy
- Percentage of patients that can avoid surgery or intervention
- Establishing an optimal surveillance protocol for patients with STMs
- Quality of Life and anxiety in patients undergoing surveillance compared with patients undergoing active treatment
- Expression of miRNA in patients with infertility and testicular tumours in serum/plasma and/or seminal plasma
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Robert Hamilton, MD
- 電話番号：416-946-2909
- メール：rob.hamilton@uhn.ca
研究連絡先のバックアップ
- 名前：Talha Chaudhry, MSc
- 電話番号：437-221-9469
- メール：talha.chaudhry3@uhn.ca
研究場所
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-
Ontario
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Toronto、Ontario、カナダ、M5G 2M9
- 募集
- Princess Margaret Cancer Centre
-
コンタクト：
- Robert Hamilton, MD
- 電話番号：4169462909
- メール：rob.hamilton@uhn.ca
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients with small testicular masses
説明
Inclusion Criteria:
-
• Small testicular mass/masses ≤ 2cm
- Patients with serum tumour marker elevation are eligible only if they are considered for surgical treatment, or if markers are felt to be falsely elevated by the physician team
- If the patient previously had chemotherapy, the mass must first have appeared only after the treatment completed
- The patient is at least 18 years of age
- Ability to understand and comply with the requirements of the study
- Ability to understand and willingness to sign a written informed consent
Exclusion Criteria:
-
• Patients with testicular tumours > 2 cm
- Metastatic disease
- Patients in reduced general condition, with uncontrolled intercurrent illnesses, or with life-threatening disease
- Patients with psychiatric illnesses that would limit compliance with study requirements
- Clinical decision is made by the multidisciplinary team that patient is not suitable for surveillance
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment Free Survival (TFS)
時間枠：2 years
|
Defined as the proportion of participants not requiring active treatment (RO or TSS) |
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
• Metastasis free survival (MFS)
時間枠：2 years
|
length of time from date of entering the study to the date of metastasis from disease. |
2 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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