NCT07100288

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jul 2025Dec 2030

First Submitted

Initial submission to the registry

July 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

July 20, 2025

Last Update Submit

July 27, 2025

Conditions

Ovarian CancerOvarian Cancer (OvCa)Ovarian Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • metastasis in infundibulopelvic ligament

    To analyze the percentage of infundibulopelvic ligament involvement by cancer in patients with FIGO stage IA-IVB ovarian cancer.

    Through study completion, an average of 5 year

Secondary Outcomes (1)

  • Presence of paraaortic lymph node metastasis

    Through study completion, an average of 5 year

Other Outcomes (3)

  • Disease Free Survival

    3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months

  • Assessment of complications

    during surgery, at hospital discharge, day 30

  • Overall survival (OS)

    60 months

Study Arms (1)

ovarian cancer patients

Other: resection of infundibulopelvic ligament

Interventions

resection of infundibulopelvic ligamentOTHER

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

ovarian cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with FIGO stage IA-IVB epithelial ovarian cancer who undergoing surgery at our center.

You may qualify if:

  • ◦ 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.

You may not qualify if:

  • ◦ 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Universitario Insular Materno Infantil de Las Palmas

Las Palmas de Gran Canaria, Spain

RECRUITING

Related Publications (3)

  • 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: 15047236BACKGROUND

  • 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: 26397066BACKGROUND

  • 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: 19361838BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

beatriz NAVARRO SANTANA, pHD

CONTACT

+34620151146bea_0904@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GYNECOLOGIST ONCOLOGIST

Study Record Dates

First Submitted

July 20, 2025

First Posted

August 3, 2025

Study Start

July 20, 2025

Primary Completion (Estimated)

July 20, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

preprint Access

Locations

ES(1)