Prognostic Value of KELIM Score and Inflammatory Markers in Ovarian Cancer
24. juni 2026 oppdatert 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Studietype
Observasjonsmessig
Registrering (Antatt)
80
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Sohag, Egypt
- Sohag university hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Progression-Free Survival (PFS)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Completeness of Interval Cytoreductive Surgery
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Antatt)
1. januar 2027
Studiet fullført (Antatt)
1. februar 2027
Datoer for studieregistrering
Først innsendt
24. juni 2026
Først innsendt som oppfylte QC-kriteriene
24. juni 2026
Først lagt ut (Faktiske)
1. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Soh-Med-26-6-3MS
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .