TRU-Cut Biopsy in Tumor cHaracterisation

Launched by GENERAL UNIVERSITY HOSPITAL, PRAGUE · Feb 5, 2025

Keywords

ClinConnect Summary

The TRU-Cut Biopsy in Tumor Characterization trial is studying a procedure called tru-cut biopsy, which is a simple way to take a small tissue sample from a tumor. This method is less invasive than traditional surgery and helps doctors to understand the tumor better, allowing them to create a more effective treatment plan while avoiding unnecessary surgery. The trial will assess how well this procedure works, how safe it is, and whether the samples collected accurately represent the tumor.

To participate in this trial, women aged 18 and older who have a pelvic or abdominal lesion that may be cancerous could be eligible. This includes those with a new diagnosis of a gynecologic tumor, those suspected of having a recurrence of a previous cancer, or those with tumors that have spread to the pelvic or abdominal areas. Participants can expect to undergo the tru-cut biopsy procedure and will be closely monitored for safety and effectiveness. It's important to know that individuals who are very early in their disease stage or those deemed unsuitable for treatment by their doctor will not be included in the study.

Gender

FEMALE

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