TRU-Cut Biopsy in Tumor cHaracterisation (TRUTH)

Tru-cut Biopsy in Tumor Characterisation

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.

Study Overview

• Status: Recruiting
• Conditions: Tumor
• Intervention / Treatment: Procedure: tru-cut biopsy

Detailed Description

The primary endpoint is represented by the assessment of adequacy, accuracy and safety of the procedure in prospective settings. The secondary endpoint is to evaluate feasibility of immunohistochemistry (IHC), next generation sequencing (NGS) and tumor immunology in obtained samples by TCB and to assess the alterations of these tumor characteristics in relation to the treatment. The additional endpoint includes the effect of several variables (e.g. tumor origin, size of the tumor, presence of ascites, body mass index (BMI), biopsy site, biopsy approach - transvaginal, transrectal vs. transabdominal, status of the disease - the first diagnosis, the first and other recurrence or progression and previous treatment modality - chemotherapy, anti-angiogenic therapy, PARP inhibitor therapy, hormonal therapy, radiotherapy) on the outcome of the procedure (adequacy, accuracy and safety).

All patients indicated for tru-cut biopsy (including advanced stages of ovarian, endometrial or cervical cancers) in Gynecologic Oncology Center of the General University Hospital from February 2024 to January 2026 will be recruited. Furthermore, all patients with suspicious recurrence or progression of already known gynecologic malignancy based on the imaging methods will be recruited. The duration of recruitment is 3 years, and we expect 250 patients enrolled into the trial. Data will be assessed in relation to the patient characteristics, tumor/lesion characteristics, procedure specifications, histopathological characteristics and IHC/NGS/immunological characteristics, consequent biopsy/surgery and final histopathological results. All adverse events will be recorded. Moreover, patient related outcomes will be recorded within 72 hours after the procedure.

This prospective study could support our hypothesis that TCB is feasible and safe procedure with high adequacy and accuracy rate. It enables to get appropriate outcomes of IHC, NGS and immunology preoperatively. We expect that TCB is applicable and efficient in majority of recurrences/disease progressions, so it can be considered suitable technique for de novo biopsy. It can help us show the alterations of tumor characteristics after the previous treatment and can be used to select appropriate targeted therapy.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Renata Poncová, MD.; Phone Number: +420731573737; Email: poncova.renata@gmail.com
• Study Contact Backup: Name: Filip Frühauf, MD.; Email: filip.fruehauf@vfn.cz

Study Locations

• Czechia
  • Praha, Czechia, 12800
    • Recruiting
    • Department of Gynecology, Obstetrics and Neonatology of First Faculty of Medicine and General University Hospital in Prague
    • Contact: Renata Poncová; Phone Number: +420731573737; Email: poncova.renata@gmail.com
    • Contact: Filip Frühauf; Email: filip.fruehauf@vfn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women with abdominopelvic tumor

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The adequacy of samples obtained by TCB for histopathological examination (in %)	1. The adequacy means the ability to determine the type of tumor (in %)	First data 31st of June 2025, definitive data 31st of January 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First data 31st of June 2025, definitive data 31st of January 2026
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.	First data 31st of June 2025, definitive data 31st of January 2026
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.	First data 31st of June 2025, definitive data 31st of January 2026

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First data 31st of June 2025, definitive data 31st of January 2026
Overall safety of TCB (in %)	6. Overall safety of TCB (in %)	First data 31st of June 2025, definitive data 31st of January 2026
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 %)	First data 31st of June 2025, definitive data 31st of January 2026

Collaborators and Investigators

• Sponsor: General University Hospital, Prague
• Investigators: Study Chair: David Cibula, prof., Department of Gynecology, Obstetrics and Neonatology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 2, 2024
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cancer; tumor; biopsy; tru-cut; core-cut; pelvic tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 10/23 Grant GIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Registration of subjects into the database using the REDCap (Research Electronic Data Capture, www.projectredcap.org) electronic data capture tool.
• IPD Sharing Time Frame: 1.2.2024 - 31.1.2026
• IPD Sharing Access Criteria: Study participation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No