TRU-Cut Biopsy in Tumor cHaracterisation
ConditionTumor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorGeneral University Hospital, Prague
About this trial
Tru-cut biopsy (TCB) is a minimally invasive method to get an adequate sample from the lesion in order to tailor the appropriate management avoiding unnecessary surgery. The aim of our trial is to evaluate the adequacy, accuracy and safety of the method related to the final histology as reference standard.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
new diagnosis of a presumed gynecologic tumor
suspicious recurrence or progression of a known gynecologic malignancy
pelvic/abdominal spread or recurrence of a non-gynecologic tumor (primary tumor or metastasis)
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
Disqualifiers
Considered by the investigator to be unsuitable for any treatment
Early stage disease
Age <18 years
Trial population
Women with abdominopelvic tumor
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
tru-cut biopsy
Procedure/Surgeryneedle biopsy from the tumor
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The adequacy of samples obtained by TCB for histopathological examination (in %)
1\. The adequacy means the ability to determine the type of tumor (in %)
Time frame
First data 31st of June 2025, definitive data 31st of January 2026Secondary outcomes
1
The adequacy of samples obtained by TCB for next-generation sequencing examination (in %)
2\. Adequacy of samples obtained by TCB for next-generation sequencing examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.
Time frame
First data 31st of June 2025, definitive data 31st of January 20262
The adequacy of samples obtained by TCB for immunohistochemistry examination (in %)
3\. Adequacy of samples obtained by TCB for immunohistochemistry examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.
Time frame
First data 31st of June 2025, definitive data 31st of January 20263
The adequacy of samples obtained by TCB for immunologic examination (in %)
4\. Adequacy of samples obtained by TCB for immunologic examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.
Time frame
First data 31st of June 2025, definitive data 31st of January 2026Other outcomes
1
1. To evaluate which factors affect the primary and secondary endpoints 2. To evaluate the overall safety of TCB (in %) 3. To evaluate the overall accuracy of TCB for complex classification of pelvic and abdominal tumors (in %)
5\. Evaluation of factors affecting the primary and secondary endpoints Includes tumor origin, size, presence of ascites, BMI, biopsy site, biopsy approach, disease status, and previous treatment modalities.
Time frame
First data 31st of June 2025, definitive data 31st of January 20262
Overall safety of TCB (in %)
6\. Overall safety of TCB (in %)
Time frame
First data 31st of June 2025, definitive data 31st of January 20263
Overall accuracy of TCB for complex classification of pelvic and abdominal tumors (in %)
7\. Overall accuracy of TCB for complex classification of pelvic and abdominal tumors (in %)
Time frame
First data 31st of June 2025, definitive data 31st of January 2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov