Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04826952 |
| Other study ID # |
20201912B0 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
