Clinical trial · Observational
TRU-Cut Biopsy in Tumor cHaracterisation
Tru-cut Biopsy in Tumor Characterisation
NCT06816160CI-TRIAL-00085676TRUTHrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tru-cut biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The adequacy of samples obtained by TCB for histopathological examination (in %)
- timeFrame
- First data 31st of June 2025, definitive data 31st of January 2026
- description
- 1\. The adequacy means the ability to determine the type of tumor (in %)
Secondary outcomes (3)
- measure
- The adequacy of samples obtained by TCB for next-generation sequencing examination (in %)
- timeFrame
- First data 31st of June 2025, definitive data 31st of January 2026
- description
- 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.
- measure
- The adequacy of samples obtained by TCB for immunohistochemistry examination (in %)
- timeFrame
- First data 31st of June 2025, definitive data 31st of January 2026
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.