Clinical trial · Interventional
Use of an Intrauterine Manipulator and Its Correlation with Positive Peritoneal Cytology in Early Stage Endometrial Cancers
NCT04570553CI-TRIAL-00087783recruitingN/AClinicalTrials.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)
This study aims to answer whether use of a Vcare® intrauterine manipulator leads to an increased incidence of positive peritoneal cytology in patients undergoing surgical management of early stage (FIGO stage I/II) endometrial cancer.
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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| surgical staging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- V-care uterine manipulator
- description
- Patients in the V-care uterine manipulator arm will undergo standard staging surgery utilizing a V-care uterine manipulator in the standard fashion
- interventionNames
- Procedure: surgical staging
- type
- ACTIVE_COMPARATOR
- label
- Sponge stick
- description
- Patients in the sponge stick arm will undergo standard staging surgery utilizing a non-invasive sponge stick for cervical delineation.
- interventionNames
- Procedure: surgical staging
Primary outcomes (1)
- measure
- Conversion of positive peritoneal cytology
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects age 18 or older able to give informed consent * Biopsy diagnosed endometrial cancer (including endometrioid, serous, mucinous and clear cell histologies) * Planned standard of care surgical management of early stage endometrial cancer * No clinical evidence of disseminated intraperitoneal disease Exclusion Criteria: * Final pathology does not reflect diagnosis of endometrial cancer (including endometrioid, serous, mucinous, and clear cell histology) * Evidence of disseminated intraperitoneal disease * Subject is not a surgical candidate * Subject elects for fertility sparing or non-operative management * Subject is unable to provide informed consent
References
Publications (22)
- BACKGROUNDWorld Cancer Research Fund/American Institute for Cancer Research. Diet, Nutrition, Physical Activity and Cancer: a Global Perspective. Continuous Update Project Expert Report 2018. Available at dietandcancerreport.org.
- BACKGROUNDCampos SM, Lee LJ, Del Carmen, MG, McMeekin DS. Corpus: Epithelial Tumors. In DS Chi, A Berchuk, DS Dizon, and CM Yashar (Eds.), Principles and Practice of Gynecologic Oncology. (pp 511) Philadelphia, PA: Wolters Kluwer.
- BACKGROUNDFung-Kee-Fung M, Dodge J, Elit L, Lukka H, Chambers A, Oliver T; Cancer Care Ontario Program in Evidence-based Care Gynecology Cancer Disease Site Group. Follow-up after primary therapy for endometrial cancer: a systematic review. Gynecol Oncol. 2006 Jun;101(3):520-9. doi: 10.1016/j.ygyno.2006.02.011. Epub 2006 Mar 23. PMID 16556457
- BACKGROUNDCreasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41. doi: 10.1002/1097-0142(19901015)60:8+3.0.co;2-8. PMID 3652025
- BACKGROUNDCreutzberg CL, van Putten WL, Koper PC, Lybeert ML, Jobsen JJ, Warlam-Rodenhuis CC, De Winter KA, Lutgens LC, van den Bergh AC, van de Steen-Banasik E, Beerman H, van Lent M. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma. Lancet. 2000 Apr 22;355(9213):1404-11. doi: 10.1016/s0140-6736(00)02139-5. PMID 10791524
- BACKGROUNDCreasman WT, Rutledge F. The prognostic value of peritoneal cytology in gynecologic malignant disease. Am J Obstet Gynecol. 1971 Jul 15;110(6):773-81. doi: 10.1016/0002-9378(71)90571-0. No abstract available. PMID 5561996
- BACKGROUNDKasamatsu T, Onda T, Katsumata N, Sawada M, Yamada T, Tsunematsu R, Ohmi K, Sasajima Y, Matsuno Y. Prognostic significance of positive peritoneal cytology in endometrial carcinoma confined to the uterus. Br J Cancer. 2003 Jan 27;88(2):245-50. doi: 10.1038/sj.bjc.6600698.