Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.
Recruiting
Observational Study
Pelvic CancerOvarian CancerCervical CancerUterus CancerEndometrial CancerOvarian NeoplasmsOvarian CarcinomaSarcoma UterusMetastatic Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 prese…
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
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