Prognostic Value of KELIM Score and Inflammatory Markers in Ovarian Cancer
24 juni 2026 uppdaterad av: Aya Ahmed Nasser
Integrative Prognostic Value of Inflammatory Markers and KELIM Score in Ovarian Cancer Patients Treated With Neoadjuvant Chemotherapy.
This is a retrospective observational study to evaluate the integrative prognostic value of inflammatory markers, specifically the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), alongside the CA-125 Elimination rate constant K (KELIM) score in advanced ovarian cancer patients.
The study includes patients with advanced serous ovarian cancer (stage III or IV) who received neoadjuvant platinum-based chemotherapy followed by interval debulking surgery at Sohag University Hospital and Sohag Cancer Center between 2022 and 2025.
The primary objective is to evaluate how well these biomarkers predict survival outcomes, including progression-free survival (PFS) and overall survival (OS).
Additionally, the study aims to assess their significance in predicting the success of complete versus incomplete cytoreductive surgery following neoadjuvant chemotherapy.
Studieöversikt
Status
Aktiv, inte rekryterande
Studietyp
Observationell
Inskrivning (Beräknad)
80
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Sohag, Egypten
- Sohag university hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
The study population consists of female patients diagnosed with advanced epithelial ovarian cancer (specifically stage III or IV high-grade serous ovarian carcinoma) who were managed and followed up at Sohag University Hospital and Sohag Cancer Center, Egypt.
Eligible participants are those who underwent a standard treatment protocol comprising platinum-based neoadjuvant chemotherapy followed by interval cytoreductive surgery between January 2022 and December 2025, and whose medical records contain comprehensive baseline hematological and tumor marker data.
Beskrivning
Inclusion Criteria:
- Female patients aged \ge 18 years old., Histologically confirmed advanced epithelial ovarian cancer (High-Grade Serous Ovarian Carcinoma), Stage III or IV.
Patients who received platinum-based neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) at Sohag University Hospital or Sohag Cancer Center between 2022 and 2025.
Available complete medical records, including pre-treatment baseline CBC (for NLR and PLR calculation) and longitudinal CA-125 levels (for KELIM score estimation).
Exclusion Criteria:
Patients with non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord-stromal tumors).
Patients who underwent primary debulking surgery (PDS) before receiving chemotherapy.
Patients with concurrent active malignancies or a history of other cancers within the past 5 years.
Patients with active systemic inflammatory diseases, hematological disorders, or severe infections at baseline that could interfere with baseline inflammatory markers (NLR/PLR).
Incomplete or missing clinical, surgical, or follow-up data.
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Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Ovarian Cancer Cohort
Advanced serous ovarian cancer patients treated with neoadjuvant chemotherapy followed by interval debulking surgery.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Progression-Free Survival (PFS)
Tidsram: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
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Evaluation of the prognostic value of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting progression-free survival in locally advanced ovarian cancer patients receiving platinum-based neoadjuvant chemotherapy followed by interval debulking surgery.
PFS is calculated as the time from the date of diagnosis to the date of first documented clinical or radiological disease progression, or death from any cause.
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From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
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Overall Survival (OS)
Tidsram: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
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Evaluation of the prognostic value of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting overall survival in locally advanced ovarian cancer patients receiving platinum-based neoadjuvant chemotherapy followed by interval debulking surgery.
OS is calculated as the time from the date of diagnosis to the date of death from any cause.
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From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Completeness of Interval Cytoreductive Surgery
Tidsram: At the time of interval debulking surgery (typically performed after 3 to 6 cycles of neoadjuvant chemotherapy).
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Evaluation of the significance of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting surgical outcomes.
The success of the interval debulking surgery will be categorized based on the presence of residual tumor into complete cytoreduction (no macroscopically visible tumor) versus incomplete cytoreduction following neoadjuvant chemotherapy.
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At the time of interval debulking surgery (typically performed after 3 to 6 cycles of neoadjuvant chemotherapy).
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Passos VF, Rodrigues LKA, Santiago SL. The effect of magnesium hydroxide-containing dentifrice using an extrinsic and intrinsic erosion cycling model. Arch Oral Biol. 2018 Feb;86:46-50. doi: 10.1016/j.archoralbio.2017.11.006. Epub 2017 Nov 14.
- Madrigal-Valverde M, Bittencourt RF, Ribeiro Filho AD, Barbosa VF, Vieira CA, Romao EA, Carneiro IB, Azevedo MC, Araujo GR. Quality of domestic cat semen collected by urethral catheterization after the use of different alpha 2-adrenergic agonists. J Feline Med Surg. 2021 Aug;23(8):745-750. doi: 10.1177/1098612X20973183. Epub 2020 Nov 18.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2026
Primärt slutförande (Beräknad)
1 januari 2027
Avslutad studie (Beräknad)
1 februari 2027
Studieregistreringsdatum
Först inskickad
24 juni 2026
Först inskickad som uppfyllde QC-kriterierna
24 juni 2026
Första postat (Faktisk)
1 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Soh-Med-26-6-3MS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
The data used in this study belong to the medical records of Sohag University Hospital and Sohag Cancer Center and contain sensitive patient clinical information.
Due to institutional policies and strict patient confidentiality regulations, individual participant data cannot be made publicly available or shared outside the participating centers.
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .