NCT06483399

Brief Summary

The goal of this observational study is to explore the influence and predictive significance of nutritional risk indicators and inflammatory indicators on postoperative complications and prognosis of patients with epithelial ovarian cancer (EOC). The main question it aims to answer is: Can preoperative nutritional risk and inflammatory indexes predict postoperative complications? Do preoperative nutritional risk and inflammatory indexes better predict the prognosis of patients with epithelial ovarian cancer? Which index is the best predictor of postoperative complications or prognosis for patients?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,108

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

January 1, 2012

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

11.2 years

First QC Date

June 24, 2024

Last Update Submit

June 27, 2024

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

  • Postoperative Complications

    Surgical complications within 30 days after comprehensive staging or cytoreductive surgery recorded according to the Clavien-Dindo grading system

    Within 30 days after surgery

  • Progression-free survival

    Interval between first diagnosis and first recurrence, death, or last follow-up

    From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of disease progression or death or last follow-up, whichever occurred first, assessed up to 100 months.

  • Overall survival

    Interval between first diagnosis and death, or last follow-up

    From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of death or last follow-up, whichever occurred first, assessed up to 100 months.

Study Arms (2)

Low [index] group

The patients were grouped according to the cut-off value of each index, and the patients whose index value was lower than the cut-off value were classified as the Low \[index\] group.

High [index] group

The patients were grouped according to the cut-off value of each index, and the patients whose index value was higher than the cut-off value were classified as the High \[index\] group.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with epithelial ovarian cancer between January 2012 and February 2023 were recruited from seven tertiary medical centers in the China Real World Gynecological Oncology Platform (NUWA).

You may qualify if:

  • histologically confirmed primary epithelial ovarian, peritoneal, and fallopian tube cancers.
  • patients received comprehensive staged surgery or debulking surgery.
  • available data of laboratory examination within 7 days before the surgery.

You may not qualify if:

  • borderline ovarian tumor.
  • receipt of neoadjuvant chemotherapy.
  • presence of other conditions influencing laboratory data, like hepatitis, kidney disease, autoimmune diseases, infectious diseases, blood disease, etc.
  • concurrent cancer in other organs.
  • absence of surgery or biopsy only.
  • multiple staged surgeries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Liu X, Li M, Zhao Y, Jiao X, Yu Y, Li R, Zeng S, Chi J, Ma G, Huo Y, Peng Z, Liu J, Zhou Q, Zou D, Wang L, Li Q, Wang J, Yao S, Chen Y, Ma D, Hu T, Gao Q. The impact of preoperative immunonutritional status on postoperative complications in ovarian cancer. J Ovarian Res. 2025 Apr 29;18(1):88. doi: 10.1186/s13048-025-01624-3.

    PMID: 40301987DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2024

First Posted

July 3, 2024

Study Start

January 1, 2012

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

July 3, 2024

Record last verified: 2024-06