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New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer

NCT06120309 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 465

Last updated 2023-11-07

No results posted yet for this study

Summary

A validated prognostic index for the outcome of advanced high-grade serous ovarian cancer (HGSOC) patients undergoing neoadjuvant chemotherapy (NACT) is still lacking. To address this need, we developed an ovarian neoadjuvant chemotherapy prognostic index (ONCPI) to improve predictive accuracy. We analyzed the clinicopathological characteristics of advanced HGSOC patients receiving platinum-based NACT. Blood inflammatory composite markers were calculated and binary-transformed using optimal cutoffs. Omental hematoxylin and eosin (H\&E) stained slides were selected for the assessment of chemotherapy response score (CRS). Logistic regression analysis and Cox proportional hazards regression model were utilized to develop a prognostic index.

Conditions

Interventions

DIAGNOSTIC_TEST

CRS scoring

For pathological evaluation, the omental specimens resected during the IDS were stained with haematoxylin and eosin (H\&E) and reviewed independently by two gynecologic pathologists, both blinded to the clinical data and each other's results. The pathology slide obtained from omentum, usually the site with the most viable tumor, was selected for CRS assessment according to the three-tiered CRS system recommended by 2019 ESMO ovarian cancer guidelines

DIAGNOSTIC_TEST

Routine blood laboratory testing before treatment

The routine blood tests and tumor marker measurements, including CA125, HE4, and inflammation-related serum biomarkers including neutrophils, lymphocytes, monocytes, fibrinogen, and platelets, were conducted within three days before the first NACT.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2023-12-01
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120309 on ClinicalTrials.gov