Minimally invasive biopsy for tumor characterization
Official title: Tru-cut Biopsy in Tumor Characterisation
Run by General University Hospital, Prague · NCT06816160 · Data updated 2026-11-12
This study is testing a less invasive way to take tissue samples from suspected tumors in women to see how well it works compared to final lab results and if it can help with more advanced tests.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | General University Hospital, Prague Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Prague) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | January 31, 2026 |
| Study ends | January 31, 2027 |
| Registry record updated | February 10, 2025 |
| Trial ID | NCT06816160 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with suspected gynecologic tumors or known malignancies showing signs of recurrence or progression.
✕Probably not a fit
Patients with early-stage disease or those deemed unsuitable for any treatment will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the adequacy, accuracy, and safety of tru-cut biopsy (TCB) in obtaining tissue samples from suspected malignant lesions. The primary focus is to assess how well TCB correlates with final histology results, while secondary objectives include exploring the feasibility of advanced analyses like immunohistochemistry and next-generation sequencing on the samples. The study will also investigate how various factors, such as tumor characteristics and patient history, influence the outcomes of the biopsy procedure. Recruitment will take place over three years, targeting patients with gynecologic tumors or suspicious lesions.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate tumor characterization and tailored treatment plans, potentially avoiding unnecessary surgeries.
How similar studies have gone: While similar approaches have been explored, this specific evaluation of tru-cut biopsy in gynecologic oncology is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Presence of a pelvic/abdominal lesion with suspicion of malignancy: 1. new diagnosis of a presumed gynecologic tumor 2. suspicious recurrence or progression of a known gynecologic malignancy 3. pelvic/abdominal spread or recurrence of a non-gynecologic tumor (primary tumor or metastasis) 4. pelvic/abdominal spread of a tumor of unknown origin 2. Age ≥18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status grade \<3 4. Not pregnant 5. Signed informed consent form Exclusion Criteria: 1. Considered by the investigator to be unsuitable for any treatment 2. Early stage disease 3. Age \<18 years
Where it's running
-
Department of Gynecology, Obstetrics and Neonatology of First Faculty of Medicine and General University Hospital in Prague
Prague, Czechia Recruiting
Study contacts
- Study coordinator: Renata Poncová, MD.
- Email: poncova.renata@gmail.com
- Phone: +420731573737
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.