Strain-elastography in Endometrial Cancer

NCT06623916 | Completed FDA Device

• 1 other identifier: 2022-179
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Strain elastography is a novel, non-invasive, easy applicable method to determine the tissue characteristics of benign or malign lesions in various organs. In this preliminary prospective study, we investigated the relation between the known pathological prognostic factors of endometrial cancer and elastographic characteristics of tumor tissue

Conditions

Endometrial Cancer

Keywords

elastography; endometrial cancer; prognosis

Outcome Measures

Primary Outcomes (1)

• feasibility; to compare the stiffness and strain character of tumor tissue with well-known pathological prognostic factors of endometrial cancer.

  The strain measurements are displayed as a semitransparent color map called an elastogram, which is overlaid on the b-mode image. Typically, low strain (stiff tissue) is displayed in blue, and high strain (soft tissue) is displayed in red, although the color scale can vary depending on the ultrasound vendor. A pseudo-quantitative measurement called the strain ratio can be used, which is the ratio of strain measured in adjacent (usually normal) reference tissue region of interest (ROI) to strain measured in a target lesion ROI. SR \>1 indicates that the target lesion compresses less than the normal reference tissue, indicating lower strain and greater stiffness.The receiver operating characteristics (ROC) analysis was used to determine whether the mean strain ratio values had a statistically significant effect on the differentiation in well known pathological prognostic factors.

  strain ratio measurements of tumor tissue were performed one night before the operation. these data were compared with pathological reports which results 1 month after the cytoreductive surgery.

Interventions

Endometrial Cancer Survivors DEVICE

strain sonoelastograghy method has not been studied before in endometrial cancer as a prognostic factor. we compared well known pathologic prognostic factors with elastographic methods.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with endometrial cancer diagnosis will be operated in gynaecologic oncology clinic in Adnan Menderes University

You may qualify if:

• Patients with epitheliel endometrial cancer diagnosis with biopsy.

You may not qualify if:

• Diagnosis of different types of tumors in the last 5 years
• Presence of synchronous malignancy, presence of non epithelial uterine tumor
• Lack of patient data
• Presence of full-thickness uterine and cervical involvement (lack of evaluation for elastography)
• Lack of patient compliance for transvaginal ultrasound
• Inoperable cases (lack of definitive pathologic report)

Sponsors & Collaborators

• Alper seyhan: lead

Study Sites (1)

Adnan Menderes University Department of Gynaecologic Oncology

Aydin, Turkey (Türkiye)

Location

Related Publications (1)

• Ong CL, Chew LE, Han NR, Ooi CC, Yeo YC, Chew SH, Wong WL, Tang PH, Teo SY. The Characteristics of Real-time Transvaginal Sono-elastography in Endometrial Cancer. J Med Ultrasound. 2022 Jan 6;30(2):101-108. doi: 10.4103/JMU.JMU_74_21. eCollection 2022 Apr-Jun.

  PMID: 35832355 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assoc. prof.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 2, 2024
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)