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临床试验/NCT04826952
NCT04826952已完成不适用

Malignant Testicular Tumors in Children: A Single Institution's 12-year Experience

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
The 1- and 5-year overall survival rates

研究概览

简要总结

Background and Objectives. Testicular neoplasms are not commonly found in children, a formidable threat if treated inappropriately. However, there is no consensus concerning their management. The study aimed to present a holistic picture of the integrated treatment of malignant testicular tumors based on our 12 years' experience.

Patients and Methods. This institutional-based retrospective cohort study evaluated clinical presentation, histopathologic diagnosis, treatment, and outcome in 42 boys with malignant neoplasm of testis treated between 2006 and 2019.

详细描述

Study Design. We retrospectively investigated the outcomes of 42 boys aged 0-19 years presenting with testicular masses. Excluding patients with incomplete records, they were treated at a tertiary referral center between May 2006 and November 2019, which were reviewed and retrospectively analyzed based on their age at the time of admission, presenting complaints, clinical and radiological findings, tumor markers, management, and follow-up. Pathology was centrally reviewed (C.H.) in patients with a tissue biopsy, but confirmation by a central review was not required before enrollment. This retrospective study was unanimously approved by the institutional review board of Chang Gung Memorial Hospital. Their parents or legal guardians provided written informed consent through an opt-out method on our hospital website following the ethical principles for medical research involving human subjects in Taiwan.

Data Collection. The evaluation included age at presentation, medical history, clinical characteristics, diagnostic procedures, treatment methods, histopathologic findings, and outcomes for every patient. All patients received the examinations of color Doppler ultrasonography of the testis and the abdomen, plain x-ray of the thorax, and serum α-fetoprotein (AFP) levels before operations. The AFP measurement is usually very high in newborns and does not decrease to normal adult levels until 8 months. Thus, the AFP levels of infants were evaluated according to reference ranges [4,5].

Surgical Technique All 42 tumors were treated surgically. We explored the groin through an inguinal incision. The testicle is gently grasped and exteriorized, and the spermatic cord and vessels within the tunica vaginalis are clamped. The resected tumor mass was sent for frozen section examination (FSE). Testis-sparing surgery was considered in patients with non-germ cell tumors. If the tumor had replaced the entire testis, a radical orchiectomy was taken. All tumors received histologic analysis. The optimal follow-up protocol included regular control visits with the physical examination, AFP measurements, and testicular sonography. Adjuvant chemotherapy was administered, depending on histopathology and TNM criteria for tumor classification. If non-germ cell tumors were assessed accurately on FSE, testis-sparing surgery could be considered an alternative treatment modality.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 19 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • aged 0-19 years presenting with malignant testicular masses

排除标准

  • patients with incomplete records

结局指标

主要结局

The 1- and 5-year overall survival rates

时间窗: between May 2006 and November 2019

Malignant testicular tumors in children:

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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