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Pelvic CancerNCT05610501

Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

An observational study of Pelvic Cancer and Ovarian Cancer, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pelvic Cancer, Ovarian Cancer, Cervical Cancer
What is being tested?
Ultrasound guided tru-cut biopsy
Type of treatment
Surgery or procedure
How many people
200 participants
Where
4 sitesin 4 countries
Study dates
1 May 2021to 30 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: All consecutive patients (> 18 years) undergoing a tru-cut biopsy at the collaborating centers for a pelvic mass.

Who may be able to join

  • 1. Following lesion criteria applicable for biopsy:
  • 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)
  • 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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  • 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
  • Suspicious primary disseminated NON-gynecologic tumor (tumor itself or metastasis)
  • 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.
  • Patients with possible recurrence of a presumably non-gynecological tumor, where histological confirmation of disease recurrence is necessary before start of treatment.
  • Solitary tumor of unknown histology localized in vaginal wall, parametria, retroperitoneum or uterine wall and can be punctured without spilling in abdominal cavity.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 4 countries.

Wouter Froyman, MD, PHD contact

+3216344202

wouter.froyman@uzleuven.be

Stefan Timmerman, MD contact

stefan.timmerman@uzleuven.be

4 sites in 4 countries

Belgium1 site, 1 recruiting

  • UZ Leuven

    Leuven

    Wouter Froyman, MD, PhD, +3216344202, wouter.froyman@uzleuven.be

    Recruiting

Other trials in Belgium

Czechia1 site, 1 recruiting

  • First Faculty of Medicine, Charles University

    Prague

    Daniela Fischerova, MD, PHD, Daniela.Fischerova@vfn.cz

    Not yet recruiting

Other trials in Czechia

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario A. Gemelli, IRCSS

    Rome

    Antonia Carla Testa, MD, PHD, antoniacarla.testa@unicatt.it

    Not yet recruiting

Other trials in Italy

Sweden1 site, 1 recruiting

  • Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset

    Stockholm

    Elisabeth Epstein, MD, PHD, elisabeth.epstein@regionstockholm.se

    Not yet recruiting

Other trials in Sweden

About this study

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.

Read the detailed description

Ovarian cancer is known to be the 4th most lethal tumour in women and has the highest mortality rate of all gynaecological malignancies. In most women, the disease is not diagnosed until advanced stage [1]. Moreover, the pelvis and ovaries in particular, are also a common place for secondary metastases. In 4% of ovarian masses, metastasis can be found from a tumour with another primary origin [2]. In primary ovarian cancer, patients may benefit from either primary debulking surgery or neoadjuvant therapy, depending on tumour staging and patients' comorbidities [5]. In recurrent disease treatment may include surgery, radiotherapy or systemic therapy, depending on primary tumour histology, extent of recurrence, previous treatment and disease-free interval [6-8]. In pelvic masses with ultrasound features suggesting metastatic disease, management will be guided by the origin of the primary tumour [9,10]. Therefore, histological diagnosis is important to select the optimal treatment strategy.

Tissue sampling by diagnostic laparoscopy or explorative laparotomy requires general anaesthesia and hospital admission, leading to higher costs and to potential surgical morbidity. Moreover, diagnostic laparoscopy is associated with a risk of port-site metastasis, ranging from 0.3-0.4% in endometrial and cervical cancer [11] and even 17-49% in advanced ovarian cancer [12,13].

Minimally invasive procedures for diagnosis include fine-needle aspiration and tru-cut biopsy.

At fine-needle aspiration the quantity and integrity of the tissue is limited, enabling cytological evaluation only [14]. Tru-cut biopsy results in a higher specificity compared to fine needle biopsy and it enables histological examination including immunohistochemistry [15,16].

A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). However, percutaneous CT-guided biopsies of deep pelvic masses are challenging because vital structures often obstruct the needle pathway [17].

Previous studies have investigated the use of ultrasound-guided biopsies for the assessment of abdominal and pelvic masses which showed a high diagnostic adequacy and minimal complication rate [4,16,18-25]. This can be done by percutaneous transabdominal approach , a transvaginal or transrectal approach.

The main goal of this prospective study is to evaluate the safety and tissue yield of ultrasound guided transvaginal or transrectal tru-cut biopsy in patients with pelvic tumors. Secondly, factors affecting the reliability of the biopsy-results will be analyzed, as well as patients' experience and pain. Finally, a comparison of biopsy results and final histological diagnosis will be performed in those patients undergoing surgical management.

  1. Study aims Primary Aim The main goal of our study is 1) to evaluate the safety (defined as absence of procedure-related complications) and 2) tissue yield (defined as sufficient amount of tissue for histological analysis) of ultrasound guided transvaginal or transrectal tru-cut biopsy in patients with pelvic masses.

Secondary Aims

  • Analyzing factors affecting the safety and tissue yield. (The influence of selected variables such as number of biopsies per target lesion, length of the shot (15 vs 22 mm), thickness of needle (16-18 G), target lesion, target lesion size, histotypes etc. on these outcomes will be assessed.)
  • Assessment of patients' overall experience, assessment of pain and discomfort during the procedure and afterwards.
  • Comparison of biopsy result with final histological diagnosis: histological type (only in patients finally undergoing surgery)

Study design Prospective multicentric observational study

Being tested
Ultrasound guided tru-cut biopsy
Keywords
Tru-cut, Ultrasound, Pelvic mass, Ovarian cancer, Gynaecologic oncology
Medical subject headings
Pelvic Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms, Endometrial Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided tru-cut biopsyProcedure or surgery

    Tru-cut biopsies can collect tissue specimens via a needle of 18G A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound

Study groups in NCT05610501
Study groupRoleWhat they receive
Patient populationAll consecutive patients (> 18 years) undergoing a tru-cut biopsy at the participating centers during the study periof will be eligible for inclusion in the study. All biopsies will be performed by trained operators in gynecologic ultrasound and tru-cut biopsies. Tissue samples will be assessed by experienced pathologists, dedicated in gynecologic oncology. Data will be collected by reviewing patients' electronic medical file including data concerning further treatment-strategy and pathology reports. Patients' level of pain and overall experience will be assessed by an independent investigator not present during biopsy. This will be performed from 0-72h after the biopsy using a numeric rating scale (0-100). Safety and complication-rate will be assessed by both using the collected data and via postprocedural assessment and by phone after six weeks. Inclusion and exclusion criteria can be found elsewhere.
Receives: Procedure: Ultrasound guided tru-cut biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Defined as absence of procedure-related complications. Procedure related complications will be graded by Clavien-Dindo classification.

    Measured: 6 weeks

  2. Tissue yield

    Defined as sufficient amount of tissue for histological analysis. This will be a binary variable based on the pathology report.

    Measured: 6 weeks after procedure

Secondary outcomes (8)

  1. Factor 1 affecting safety and tissue yield

    A number of biopsies per target lesion,

    Measured: 6 weeks

  2. Factor 2 affecting safety and tissue yield

    The length of the needle shot (15 vs 22 mm).

    Measured: 6 weeks

  3. Factor 3 affecting safety and tissue yield

    The thickness of needle (16-18 Gauge).

    Measured: 6 weeks

  4. Factor 4 affecting safety and tissue yield

    The target lesion histotype - categorical variable defined by the tumour type.

    Measured: 6 weeks

  5. Factor 5 affecting safety and tissue yield

    The target lesion size in mm.

    Measured: 6 weeks

  6. Patient experience

    Assessment of patients' overall experience using VAS-Score.

    Measured: 3 days

  7. Patient pain score

    Assessment of patients' pain and discomfort during the procedure using VAS-Score.

    Measured: 3 days

  8. Histological diagnosis

    Comparison of biopsy result with final histological diagnosis: histological type (only in patients finally undergoing surgery). Binary variable indicating agreement.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start1 May 2021
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610501
Sponsor's protocol ID
S64793
Status last verified
Jul 2024
First submitted
28 Sep 2022
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chandra A, Pius C, Nabeel M, Nair M, Vishwanatha JK, Ahmad S, Basha R. Ovarian cancer: Current status and strategies for improving therapeutic outcomes. Cancer Med. 2019 Nov;8(16):7018-7031. doi: 10.1002/cam4.2560. Epub 2019 Sep 27.

    PubMed 31560828

  • Van Calster B, Van Hoorde K, Valentin L, Testa AC, Fischerova D, Van Holsbeke C, Savelli L, Franchi D, Epstein E, Kaijser J, Van Belle V, Czekierdowski A, Guerriero S, Fruscio R, Lanzani C, Scala F, Bourne T, Timmerman D; International Ovarian Tumour Analysis Group. Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study. BMJ. 2014 Oct 15;349:g5920. doi: 10.1136/bmj.g5920.

    PubMed 25320247

  • Testa AC, Ferrandina G, Timmerman D, Savelli L, Ludovisi M, Van Holsbeke C, Malaggese M, Scambia G, Valentin L. Imaging in gynecological disease (1): ultrasound features of metastases in the ovaries differ depending on the origin of the primary tumor. Ultrasound Obstet Gynecol. 2007 May;29(5):505-11. doi: 10.1002/uog.4020.

    PubMed 17444565

  • Epstein E, Van Calster B, Timmerman D, Nikman S. Subjective ultrasound assessment, the ADNEX model and ultrasound-guided tru-cut biopsy to differentiate disseminated primary ovarian cancer from metastatic non-ovarian cancer. Ultrasound Obstet Gynecol. 2016 Jan;47(1):110-6. doi: 10.1002/uog.14892.

    PubMed 25925783

  • Vergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

    PubMed 20818904

  • Peiretti M, Zapardiel I, Zanagnolo V, Landoni F, Morrow CP, Maggioni A. Management of recurrent cervical cancer: a review of the literature. Surg Oncol. 2012 Jun;21(2):e59-66. doi: 10.1016/j.suronc.2011.12.008. Epub 2012 Jan 14.

    PubMed 22244884

  • Al Rawahi T, Lopes AD, Bristow RE, Bryant A, Elattar A, Chattopadhyay S, Galaal K. Surgical cytoreduction for recurrent epithelial ovarian cancer. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD008765. doi: 10.1002/14651858.CD008765.pub3.

    PubMed 23450588

  • Bradford LS, Rauh-Hain JA, Schorge J, Birrer MJ, Dizon DS. Advances in the management of recurrent endometrial cancer. Am J Clin Oncol. 2015 Apr;38(2):206-12. doi: 10.1097/COC.0b013e31829a2974.

    PubMed 23764681

  • Van Calster B, Van Hoorde K, Froyman W, Kaijser J, Wynants L, Landolfo C, Anthoulakis C, Vergote I, Bourne T, Timmerman D. Practical guidance for applying the ADNEX model from the IOTA group to discriminate between different subtypes of adnexal tumors. Facts Views Vis Obgyn. 2015;7(1):32-41.

    PubMed 25897370

  • Agnes A, Biondi A, Ricci R, Gallotta V, D'Ugo D, Persiani R. Krukenberg tumors: Seed, route and soil. Surg Oncol. 2017 Dec;26(4):438-445. doi: 10.1016/j.suronc.2017.09.001. Epub 2017 Sep 12.

    PubMed 29113663

  • Martinez A, Querleu D, Leblanc E, Narducci F, Ferron G. Low incidence of port-site metastases after laparoscopic staging of uterine cancer. Gynecol Oncol. 2010 Aug 1;118(2):145-50. doi: 10.1016/j.ygyno.2010.03.011. Epub 2010 May 7.

    PubMed 20451983

  • Vergote I, Marquette S, Amant F, Berteloot P, Neven P. Port-site metastases after open laparoscopy: a study in 173 patients with advanced ovarian carcinoma. Int J Gynecol Cancer. 2005 Sep-Oct;15(5):776-9. doi: 10.1111/j.1525-1438.2005.00135.x.

    PubMed 16174223

  • Heitz F, Ognjenovic D, Harter P, Kommoss S, Ewald-Riegler N, Haberstroh M, Gomez R, Barinoff J, Traut A, du Bois A. Abdominal wall metastases in patients with ovarian cancer after laparoscopic surgery: incidence, risk factors, and complications. Int J Gynecol Cancer. 2010 Jan;20(1):41-6. doi: 10.1111/IGC.0b013e3181c443ba.

    PubMed 20057285

  • Malmstrom H. Fine-needle aspiration cytology versus core biopsies in the evaluation of recurrent gynecologic malignancies. Gynecol Oncol. 1997 Apr;65(1):69-73. doi: 10.1006/gyno.1996.4606.

    PubMed 9103393

  • Chojniak R, Isberner RK, Viana LM, Yu LS, Aita AA, Soares FA. Computed tomography guided needle biopsy: experience from 1,300 procedures. Sao Paulo Med J. 2006 Jan 5;124(1):10-4. doi: 10.1590/s1516-31802006000100003. Epub 2006 Apr 3.

    PubMed 16612456

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Cancer and Ovarian Cancer, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, Czechia, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wouter Froyman, MD, PHD (+3216344202, wouter.froyman@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610501, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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