NCT06120309

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 465 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. The clinicopathological data of patients newly diagnosed with high-grade serous ovarian cancer in Sun Yat-sen Memorial Hospital were collected and screened. 2. Statistical analysis of hematological indicators that may be related to inflammation before platinum-based therapy in patients who met the inclusion criteria, including but not limited to: Absolute white blood cell count, absolute neutrophil count, absolute lymphocyte count, absolute monocyte count, platelet count, hemoglobin and fibrinogen were calculated. NLR, MLR, PLR, FLR and SII were calculated, and the correlation between the above indicators and tumor grade, stage, platinum-based drug sensitivity and prognosis was analyzed. 3. CRS scoring was performed using H\&E sections of omentum obtained during IDS surgery. 4. logistic regression and Cox regression were used to analyze the independent risk factors affecting the sensitivity of neoadjuvant platinum-based chemotherapy and the prognosis of patients. 5. K-M analysis and ROC curve were used to analyze the predictive value of NLR combined with CRS ONCPI index for the response of high-grade serous ovarian cancer to platinum therapy.

Conditions

• Ovarian Cancer
• Neoadjuvant Chemotherapy
• Prognostic Cancer Model

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2023-12-01
• Completion: 2024-12-31
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: China