TRU-Cut Biopsy in Tumor cHaracterisation

NCT ID: NCT06816160

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2027-01-31

Brief Summary

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.

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.

Conditions

Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

tru-cut biopsy

needle biopsy from the tumor

Intervention Type: PROCEDURE

Other Intervention Names

core-cut biopsy

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

General University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Renata Poncová

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Cibula, prof.

Role: STUDY_CHAIR

Department of Gynecology, Obstetrics and Neonatology

Locations

Department of Gynecology, Obstetrics and Neonatology of First Faculty of Medicine and General University Hospital in Prague

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Renata Poncová, MD.

Role: CONTACT

poncova.renata@gmail.com

+420731573737

Filip Frühauf, MD.

Role: CONTACT

filip.fruehauf@vfn.cz

Facility Contacts

Renata Poncová

Role: primary

poncova.renata@gmail.com

+420731573737

Filip Frühauf

Role: backup

filip.fruehauf@vfn.cz

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

10/23 Grant GIP

Identifier Type: -

Identifier Source: org_study_id