Minimally invasive biopsy for tumor characterization

Tru-cut Biopsy in Tumor Characterisation

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
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: General University Hospital, Prague (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Prague)
• Trial ID: NCT06816160 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with suspected gynecologic tumors or known malignancies showing signs of recurrence or progression.

Not a fit: Patients with early-stage disease or those deemed unsuitable for any treatment will not benefit from this study.

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 performed: While similar approaches have been explored, this specific evaluation of tru-cut biopsy in gynecologic oncology is relatively novel.

Eligibility 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 this trial is running

Prague

• 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.

Conditions Tumor; tumor; biopsy; tru-cut; core-cut; cancer; pelvic tumor