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Recruiting NCT07100288

Anatomopathological Analysis of the Infundibulopelvic Ligament in Patients With Ovarian Cancer

Observational Ovarian Cancer Ovarian Cancer (OvCa) Ovarian Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: resection of infundibulopelvic ligament.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Ovarian Cancer (OvCa), Ovarian Adenocarcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Involvement of the infundibulopelvic ligament in ovarian cancer may be associated with decreased survival and related to paraaortic lymph node metastasis

Interventions

  • Other resection of infundibulopelvic ligament
    Therefore, this study also aims to perform bilateral infundibulopelvic ligament resection (at least 8 cm in length) during surgery for ovarian cancer patients

Primary outcome measures

  • metastasis in infundibulopelvic ligament [Time frame: Through study completion, an average of 5 year]
Secondary outcome measures (1)
  • Presence of paraaortic lymph node metastasis [Time frame: Through study completion, an average of 5 year]

Eligibility criteria

Inclusion criteria

  • ◦ Patients with epithelial ovarian cancer, including high- and low-grade serous, high- and low-grade endometrioid, mucinous (expansile and infiltrative types), and carcinosarcoma.
  • FIGO 2014 stage IA-IVB.
  • Patients undergoing primary surgery or interval surgery after 3-4 or 6 cycles of chemtherapy
  • Patients with no residual disease after surgery.
  • Patients with ECOG performance status 0-1.

Exclusion criteria

  • ◦ Patients without epithelial ovarian cancer.
  • Patients with ECOG 2-4.
  • Patients who do not consent to participate in the study.
  • Patients who did not undergo complete staging surgery (including hysterectomy, bilateral salpingo-oophorectomy, pelvic and para-aortic lymphadenectomy, and omentectomy) or with residual disease after cytoreductive surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Complejo Universitario Insular Materno Infantil de Las Palmas — Las Palmas de Gran Canaria

Publications

  • Tozzi R, Kohler C, Ferrara A, Schneider A. Laparoscopic treatment of early ovarian cancer: surgical and survival outcomes. Gynecol Oncol. 2004 Apr;93(1):199-203. doi: 10.1016/j.ygyno.2004.01.004. PMID 15047236
  • Kleppe M, Kraima AC, Kruitwagen RF, Van Gorp T, Smit NN, van Munsteren JC, DeRuiter MC. Understanding Lymphatic Drainage Pathways of the Ovaries to Predict Sites for Sentinel Nodes in Ovarian Cancer. Int J Gynecol Cancer. 2015 Oct;25(8):1405-14. doi: 10.1097/IGC.0000000000000514. PMID 26397066
  • Fennimore IA, Simon NL, Bills G, Dryfhout VL, Schniederjan AM. Extension of ovarian tissue into the infundibulopelvic ligament beyond visual margins. Gynecol Oncol. 2009 Jul;114(1):61-3. doi: 10.1016/j.ygyno.2009.03.006. Epub 2009 Apr 9. PMID 19361838

Identifiers

NCT: NCT07100288 · 2024-430-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗