Ultrasound-guided Tru-cut Biopsy in Patients with Suspected Ovarian Cancer: Adequacy, Accuracy, Safety and Patient Assessment.

NCT06689605 | Recruiting

• 1 other identifier: 202411 P05
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective observational study is to evaluate the role of ultrasound-guided tru-cut biopsy (in the hands of an expert certified sonographer within a gynecological center)in patients with suspected ovarian cancer. The main questions it aims to answer are: Is the material from tru-cut biopsy adequate for histopathological and immunohistochemical examination? Is the material accurate in comparison with the final pathological specimen? What are the patient experience and complications after the procedure? Participants who will undergo a standard tru-cut biopsy procedure will need to additionally answer the questionnaire.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; tru-cut biopsy; expert ultrasonography

Outcome Measures

Primary Outcomes (1)

• Adequacy of tru-cut biopsy in ovarian cancer

  Evaluation of the adequacy of the procedure in diagnosing ovarian cancer by histopathological and immunohistochemical examination.

  From the tru-cut biopsy to the histopathological result.

Secondary Outcomes (1)

• Accuracy of tru-cut biopsy in ovarian cancer

  From the tru-cut biopsy to the definitive histopathological examination from the surgery.

Other Outcomes (1)

• Patient assesment

  From the tru-cut biopsy to the first follow-up visit.

Eligibility Criteria

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

Study Population

Patients with suspected advanced ovarian cancer

You may qualify if:

• suspected advanced ovarian cancer
• indication for tru-cut biopsy by multidisciplinary oncoboard

You may not qualify if:

• patient deny to undergo tru-cut biopsy

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

Univeristy Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A small amount of tissue from a tru-cut biopsy from ovarian cancer

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Munachiso Iheme Ndukwe, MD

CONTACT

+420725176291; munachiso.ndukwe@fnhk.cz

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 14, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2024-11

Locations

CZ (1)