Clinical trial NCT04826952: Malignant Testicular Tumors in Children: A Single Institution's 12-year Experience
Official title: Malignant Testicular Tumors in Children: A Single Institution's 12-year Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overall Survival Rates
Keywords: Testicular tumor, children, histology, orchiectomy, inguinal approach
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 42
Sex: MALE
Minimum age (years): 0
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* aged 0-19 years presenting with malignant testicular masses

Exclusion Criteria:

* patients with incomplete records

Primary outcomes:
measure: The 1- and 5-year overall survival rates
timeFrame: between May 2006 and November 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Other
Study officials:
References: