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Trial Title:
New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer
NCT ID:
NCT06120309
Condition:
Ovarian Cancer
Neoadjuvant Chemotherapy
Prognostic Cancer Model
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
High-grade serous ovarian cancer
Neoadjuvant chemotherapy
Prognostic index
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CRS scoring
Description:
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
Arm group label:
NACT Group
Intervention type:
Diagnostic Test
Intervention name:
Routine blood laboratory testing before treatment
Description:
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.
Arm group label:
NACT Group
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.
Criteria for eligibility:
Study pop:
Patients with advanced HGSOC receiving platinum-based neoadjuvant chemotherapy (NACT)
before interval debulking surgery (IDS) and postoperative adjuvant chemotherapy were
enrolled
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. confirmed diagnosis of HGSOC by two experienced pathologists;
2. clinical stage III-IV according to the 2018 International Federation of Gynecology
and Obstetrics (FIGO) guideline;
3. Eastern Cooperative Oncology Group (ECGO) performance status of 0 to 1;
4. no prior anti-cancer therapy;
5. received ≥ 3 cycles of platinum-based NACT followed by IDS;
6. complete pretreatment blood test results and clinical and imaging data.
Exclusion Criteria:
1. other pathological types;
2. without NACT or IDS;
3. incomplete pretreatment data;
4. lost to follow-up.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
520120
Country:
China
Start date:
November 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120309
