Summary
In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination. This clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.
Key Facts
Lead Sponsor
Enrollment
Start Date
Completion Date
Study Type
Official Title
Interventions
Conditions
Eligibility
Age Range
Sex
Inclusion Criteria:
* 1\. Following lesion criteria applicable for biopsy:
1. Lesion safely accessible (no visceral or vessel interposition; in the case of a transvaginal approach no vaginal stenosis (severe atrophy - virgo - vaginismus); within reach of biopsy needle)
2. Solid component present (purely cystic lesions excluded)
2\. Biopsy for research purposes, the following is applicable: Patients with a gynecological tumor eligible for participation in academic or commercial clinical trials requesting a biopsy for translational research. For the current study, which is observational, we do not intend to take additional biopsies outside routine clinical practice, but only biopsies requested for participation in other (interventional) studies on systemic treatment in gynecologic oncology.
3\. In case of a diagnostic biopsy, one of the following inclusion criteria should be applicable:
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1. Suspicious primary disseminated gynecologic tumor (tumor itself or metastasis) Patients with a presumable new diagnosis of a disseminated pelvic tumor where histological confirmation of disease is necessary before the possibility to start a specific oncologic treatment and
* Are invalid candidates for primary (radical) surgery due to comorbidities or poor overall general wellbeing
* Are invalid candidates for primary (radical) surgery due to the extensive disease-spread according to imaging and/or diagnostic laparoscopy
2. Suspicious primary disseminated NON-gynecologic tumor (tumor itself or metastasis)
3. Patients with possible recurrence of a gynecological tumor (cervix, myometrial, endometrial, ovarian etc), where histological confirmation of disease recurrence is necessary before the possibility to start a surgical or systemic intervention.
4. Patients with possible recurrence of a presumably non-gynecological tumor, where histological confirmation of disease recurrence is necessary before start of treatment.
5. Solitary tumor of unknown histology localized in vaginal wall, parametria, retroperitoneum or uterine wall and can be punctured without spilling in abdominal cavity.
Exclusion Criteria:
\- 1. Patients \< 18 years 2. Clotting defect or anticoagulation therapy, precluding a safe biopsy even with adapted therapy regimen.
3\. Vaginal or pelvic infection 4. Poor performance status contraindicating any specific oncologic treatment