NCT06231329

Brief Summary

The aim of study is to differentiate between testicular tumors by their elastographic criteria (Stiffness \[hard to soft\] , Shape under compression , etc.) using ultrasound elastography techniques (shear wave/strain elastography) on suspected testicle that showed specific lesion on normal ultrasound examination.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

January 20, 2024

Last Update Submit

February 26, 2024

Conditions

Testicular Cancer

Outcome Measures

Primary Outcomes (1)

  • collect data of our elastography examination and acknowledge more information about certain testicular tumors and percentage of malignant and bengin tumors of our specimen using ultrasound machine shear wave mode

    differentiate between certain types of testicular tumors according to their elastography criteria using ultrasound machine shear wave mode according to the elasticity of tumor tissue

    baseline

Interventions

ultrasound elastographyDEVICE

examining patient's testis with ultrasound elastography technique and collect data and results

Eligibility Criteria

Age15 Years - 65 Years
Sexmale(Gender-based eligibility)
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

male patients with testicular mass lesion

You may qualify if:

  • i. Age : (15-65 years).
  • ii. Patient with history of testicular pain or discomfort or even without clinical symptoms.
  • iii. Patient with any predisposing factors as mentioned before in the background.
  • iv. Patient with history of cancer of other organs (not testicular tumors).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Stephenson A, Eggener SE, Bass EB, Chelnick DM, Daneshmand S, Feldman D, Gilligan T, Karam JA, Leibovich B, Liauw SL, Masterson TA, Meeks JJ, Pierorazio PM, Sharma R, Sheinfeld J. Diagnosis and Treatment of Early Stage Testicular Cancer: AUA Guideline. J Urol. 2019 Aug;202(2):272-281. doi: 10.1097/JU.0000000000000318. Epub 2019 Jul 8.

    PMID: 31059667BACKGROUND

  • Gilligan T, Lin DW, Aggarwal R, Chism D, Cost N, Derweesh IH, Emamekhoo H, Feldman DR, Geynisman DM, Hancock SL, LaGrange C, Levine EG, Longo T, Lowrance W, McGregor B, Monk P, Picus J, Pierorazio P, Rais-Bahrami S, Saylor P, Sircar K, Smith DC, Tzou K, Vaena D, Vaughn D, Yamoah K, Yamzon J, Johnson-Chilla A, Keller J, Pluchino LA. Testicular Cancer, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Dec;17(12):1529-1554. doi: 10.6004/jnccn.2019.0058.

    PMID: 31805523BACKGROUND

  • Wood L, Kollmannsberger C, Jewett M, Chung P, Hotte S, O'Malley M, Sweet J, Anson-Cartwright L, Winquist E, North S, Tyldesley S, Sturgeon J, Gospodarowicz M, Segal R, Cheng T, Venner P, Moore M, Albers P, Huddart R, Nichols C, Warde P. Canadian consensus guidelines for the management of testicular germ cell cancer. Can Urol Assoc J. 2010 Apr;4(2):e19-38. doi: 10.5489/cuaj.815. No abstract available.

    PMID: 20368885BACKGROUND

  • Kreydin EI, Barrisford GW, Feldman AS, Preston MA. Testicular cancer: what the radiologist needs to know. AJR Am J Roentgenol. 2013 Jun;200(6):1215-25. doi: 10.2214/AJR.12.10319.

    PMID: 23701056BACKGROUND

  • Necas M, Muthupalaniappaan M, Barnard C. Ultrasound morphological patterns of testicular tumours, correlation with histopathology. J Med Radiat Sci. 2021 Mar;68(1):21-27. doi: 10.1002/jmrs.426. Epub 2020 Sep 1.

    PMID: 32869524BACKGROUND

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ali Mohamed Alaa El-din

CONTACT

01117630111senior1of1key@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident at radiology department

Study Record Dates

First Submitted

January 20, 2024

First Posted

January 30, 2024

Study Start

April 1, 2024

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

February 28, 2024

Record last verified: 2024-02