Actively Recruiting
Tru-cut Biopsy in Tumor Characterisation for Gynecologic and Pelvic Lesions
Led by General University Hospital, Prague · Updated on 2025-02-10
250
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the adequacy, accuracy, and safety of tru-cut biopsy (TCB), a minimally invasive method to obtain tumor samples for better treatment management. This study focuses on patients with suspected gynecologic tumors, including ovarian, endometrial, or cervical cancers, as well as other pelvic or abdominal tumors or recurrences. The goal is to confirm whether TCB can replace unnecessary surgery by providing reliable tissue samples. The procedure studied is a needle biopsy from the tumor, performed in several ways such as transvaginal, transrectal, or transabdominal approaches. The study will also assess how well TCB samples work for advanced tests like immunohistochemistry, next-generation sequencing, and tumor immunology, and how tumor characteristics may change after treatments like chemotherapy or radiotherapy. Patients will be recruited over three years, with data collected on biopsy results, tumor features, and any side effects or complications. Participants will undergo the biopsy procedure and be monitored for outcomes such as sample adequacy for various lab tests and safety within 72 hours after biopsy. Researchers will collect data on patient and tumor characteristics, treatment history, and biopsy details. The main outcome measure is the percentage of adequate samples for histopathology, with additional measures on suitability for advanced testing. The study will end in January 2027 after completing data analysis and follow-up.
CONDITIONS
Brief Title
TRU-Cut Biopsy in Tumor cHaracterisation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of a pelvic or abdominal lesion suspected to be malignant
- New diagnosis of a presumed gynecologic tumor
- Suspicious recurrence or progression of a known gynecologic cancer
- Pelvic or abdominal spread or recurrence of a non-gynecologic tumor
- Spread of a tumor of unknown origin in the pelvic or abdominal area
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status less than 3
- Not pregnant
- Signed informed consent form
You will not qualify if you...
- Considered unsuitable for any treatment by the investigator
- Early stage disease
- Age younger than 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure on a single day
Participants undergo tru-cut biopsy, a needle biopsy from the tumor, to obtain samples for histopathological, immunohistochemistry, next-generation sequencing, and immunologic examinations.
1 visit (in-person)
Duration - Up to 3 days after biopsy
Participants are observed after the biopsy procedure to assess safety, adequacy, and accuracy of the biopsy, as well as to monitor patient-related outcomes within 72 hours post-procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Gynecology, Obstetrics and Neonatology of First Faculty of Medicine and General University Hospital in Prague
Prague, Czechia, 12800
Actively Recruiting
Research Team
R
Renata Poncová, MD.
F
Filip Frühauf, MD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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