Ovarian CancerINFPELVNCT07100288
Anatomopathological Analysis of the Infundibulopelvic Ligament in Patients With Ovarian Cancer
An observational study of Ovarian Cancer and Ovarian Cancer (OvCa), run by Complejo Hospitalario Universitario Insular Materno Infantil at 1 site in Spain.
Trial summary
Involvement of the infundibulopelvic ligament in ovarian cancer may be associated with decreased survival and related to paraaortic lymph node metastasis Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Cancer (OvCa), Ovarian Adenocarcinoma
- What is being tested?
- resection of infundibulopelvic ligament
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2025to 30 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with FIGO stage IA-IVB epithelial ovarian cancer who undergoing surgery at our center.
Who may be able to join
- ◦ 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.
Who cannot join
- ◦ 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Complejo Universitario Insular Materno Infantil de Las Palmas
Las Palmas de Gran Canaria
Alicia Martin Martinez, phd, +34649088104, aliciammartinez@gmail.com
bea_0904@hotmail.com
About this study
Involvement of the infundibulopelvic ligament in ovarian cancer may be associated with decreased survival and related to paraaortic lymph node metastasis
- Being tested
- resection of infundibulopelvic ligament
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ovarian cancer patients | Not described Receives: Other: resection of infundibulopelvic ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
metastasis in infundibulopelvic ligament
To analyze the percentage of infundibulopelvic ligament involvement by cancer in patients with FIGO stage IA-IVB ovarian cancer.
Measured: Through study completion, an average of 5 year
Secondary outcomes (1)
Presence of paraaortic lymph node metastasis
Evaluation of histologically positive para-aortic lymph nodes in patients with metastasis in the infundibulopelvic ligament
Measured: Through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start20 Jul 2025
- Primary completion20 Jul 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Universitario Insular Materno Infantil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Fatima Navarro Santana, Complejo Hospitalario Universitario Insular Materno Infantil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100288
- Sponsor's protocol ID
- 2024-430-1
- Acronym
- INFPELV
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15047236Kleppe 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.
PubMed 26397066Fennimore 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.
PubMed 19361838
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomopathological Analysis of the Infundibulopelvic Ligament in Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07100288
- Acronym / sponsor ID
- INFPELV / 2024-430-1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Complejo Hospitalario Universitario Insular Materno InfantilUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Jul 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Involvement of the infundibulopelvic ligament in ovarian cancer may be associated with decreased survival and related to paraaortic lymph node metastasis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ovarian cancer patients | – | Other: resection of infundibulopelvic ligament |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with FIGO stage IA-IVB epithelial ovarian cancer who undergoing surgery at our center.
Key inclusion criteria (5 listed)
- ◦ Patients with epithelial ovarian cancer, including high- and low-grade serous, high- and low-grade endometrioid, mucinous (expansile and infiltrative types), and carcinosarcoma.
Key exclusion criteria (4 listed)
- ◦ Patients without epithelial ovarian cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resection of infundibulopelvic ligamentTherefore, this study also aims to perform bilateral infundibulopelvic ligament resection (at least 8 cm in length) during surgery for ovarian cancer patients | Other | ovarian cancer patients |
Primary outcome
metastasis in infundibulopelvic ligament
Time frame: Through study completion, an average of 5 year
To analyze the percentage of infundibulopelvic ligament involvement by cancer in patients with FIGO stage IA-IVB ovarian cancer.
1 secondary outcome
Presence of paraaortic lymph node metastasis
Time frame: Through study completion, an average of 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Results publication: PubMed 15047236Tozzi 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.
- Results publication: PubMed 26397066Kleppe 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.
- Results publication: PubMed 19361838Fennimore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Ovarian Cancer (OvCa), run by Complejo Hospitalario Universitario Insular Materno Infantil at 1 site in Spain.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact beatriz NAVARRO SANTANA, pHD (+34620151146, bea_0904@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metastasis in infundibulopelvic ligament (time frame: Through study completion, an average of 5 year). 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 NCT07100288, which also lists 3 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 Aug 2025.