New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer
NCT ID: NCT06120309
Last Updated: 2023-11-07
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
465 participants
OBSERVATIONAL
2023-11-01
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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NACT Group
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
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
2. without NACT or IDS;
3. incomplete pretreatment data;
4. lost to follow-up.
18 Years
75 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Locations
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The Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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Hudry D, Becourt S, Scambia G, Fagotti A. Primary or Interval Debulking Surgery in Advanced Ovarian Cancer: a Personalized Decision-a Literature Review. Curr Oncol Rep. 2022 Dec;24(12):1661-1668. doi: 10.1007/s11912-022-01318-9. Epub 2022 Aug 15.
Colombo N, Sessa C, du Bois A, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent diseasedagger. Ann Oncol. 2019 May 1;30(5):672-705. doi: 10.1093/annonc/mdz062.
Liang WF, Wang LJ, Li H, Liu CH, Wu MF, Li J. The added value of CA125 normalization before interval debulking surgery to the chemotherapy response score for the prognostication of ovarian cancer patients receiving neoadjuvant chemotherapy for advanced disease. J Cancer. 2021 Jan 1;12(3):946-953. doi: 10.7150/jca.52711. eCollection 2021.
Li C, Wu J, Jiang L, Zhang L, Huang J, Tian Y, Zhao Y, Liu X, Xia L, E H, Gao P, Hou L, Yang M, Ma M, Su C, Zhang H, Chen H, She Y, Xie D, Luo Q, Chen C. The predictive value of inflammatory biomarkers for major pathological response in non-small cell lung cancer patients receiving neoadjuvant chemoimmunotherapy and its association with the immune-related tumor microenvironment: a multi-center study. Cancer Immunol Immunother. 2023 Mar;72(3):783-794. doi: 10.1007/s00262-022-03262-w. Epub 2022 Sep 3.
Rodolakis I, Pergialiotis V, Liontos M, Haidopoulos D, Loutradis D, Rodolakis A, Bamias A, Thomakos N. Chemotherapy Response Score in Ovarian Cancer Patients: An Overview of Its Clinical Utility. J Clin Med. 2023 Mar 10;12(6):2155. doi: 10.3390/jcm12062155.
Other Identifiers
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SYSKY-2023-963-01
Identifier Type: -
Identifier Source: org_study_id
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