NCT04826952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 28, 2021

Last Update Submit

March 31, 2021

Conditions

Keywords

Testicular tumor, children, histology, orchiectomy, inguinal approach

Outcome Measures

Primary Outcomes (1)

  • The 1- and 5-year overall survival rates

    Malignant testicular tumors in children:

    between May 2006 and November 2019

Interventions

OrchiectomyPROCEDURE

Childhood testicular tumors deserve special diagnostic attention from the therapeutic point of view. A testicular tumor should be considered malignant until proven otherwise. In cases with suspicion of testicular tumors, the inguinal approach is preferred to the scrotal approach for scrotal violation.

Eligibility Criteria

Age0 Years - 19 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsWe retrospectively investigated the outcomes of 42 boys aged 0-19 years presenting with testicular masses.
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • aged 0-19 years presenting with malignant testicular masses

You may not qualify if:

  • patients with incomplete records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Other, 33315, Taiwan

Location

MeSH Terms

Conditions

Testicular Neoplasms

Interventions

Orchiectomy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

CastrationEndocrine Surgical ProceduresSurgical Procedures, OperativeUrogenital Surgical ProceduresUrologic Surgical Procedures, MaleUrologic Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2021

First Posted

April 1, 2021

Study Start

December 1, 2020

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations