Ovarian cancer: Current status and strategies for improving therapeutic outcomes.
Ashwin Chandra, Cima Pius, Madiha Nabeel...
https://pubmed.ncbi.nlm.nih.gov/31560828Actively Recruiting
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
200
Participants Needed
4
Research Sites
N/A
Total Duration
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
UZ Leuven, Leuven, Belgium
Collaborating Sponsor
Ovarian cancer is a leading cause of death among gynecological cancers, often diagnosed late and sometimes involving metastases from other primary tumors. This research aims to evaluate the safety and tissue yield of ultrasound-guided transvaginal or transrectal tru-cut biopsy in patients with pelvic tumors. The study also looks at factors influencing biopsy reliability, patient experience, pain, and compares biopsy results to final surgical histology when available. Participants undergo a minimally invasive tru-cut biopsy using an 18G needle guided by ultrasound to collect tissue samples from pelvic masses. The biopsies are performed by experienced gynecologic ultrasound operators, and tissue is analyzed by specialized pathologists. The study is observational and collects data on safety, tissue adequacy, patient pain and experience, and correlates biopsy findings with surgery outcomes if applicable. During the study, patients' pain and overall experience are assessed within 72 hours post-biopsy using a numeric rating scale. Safety and complication rates are monitored up to six weeks after the procedure through data review and follow-up assessments including phone calls. The main outcomes measured at six weeks are safety (absence of complications) and tissue yield (sufficient tissue for analysis). Secondary outcomes include factors affecting these results, patient discomfort, and histological diagnosis accuracy.
CONDITIONS
Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - Day of biopsy procedure and up to 3 days afterwards
Participants undergo an ultrasound-guided tru-cut biopsy to collect tissue samples from pelvic masses for histological analysis and to evaluate safety and tissue yield.
1 biopsy procedure visit plus follow-up pain and experience assessment within 3 days
Duration - 6 weeks
Participants are monitored for procedure-related complications and biopsy tissue adequacy, with clinical data collected and assessed up to 6 weeks after the biopsy.
Post-procedure assessment and phone follow-up approximately 6 weeks after biopsy
Total: 4 locations
1
UZ Leuven
Leuven, Belgium
Actively Recruiting
2
First Faculty of Medicine, Charles University
Prague, Czechia
Not Yet Recruiting
3
Fondazione Policlinico Universitario A. Gemelli, IRCSS
Rome, Italy
Not Yet Recruiting
4
Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset
Stockholm, Sweden
Not Yet Recruiting
W
Wouter Froyman, MD, PHD
S
Stefan Timmerman, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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