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NCT Number: NCT07678008

Prognostic Value of KELIM Score and Inflammatory Markers in Ovarian Cancer

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.

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Key information

Conditions

Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy High-grade Serous Ovarian Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sohag university hospital

Sohag, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).

    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.

  2. Overall Survival (OS)

    Time frame: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).

    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.

Secondary outcomes

  1. Completeness of Interval Cytoreductive Surgery

    Time frame: At the time of interval debulking surgery (typically performed after 3 to 6 cycles of neoadjuvant chemotherapy).

    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.

Sponsors and collaborators

Lead sponsor

Aya Ahmed Nasser

Other

Registry information

Official study title

Integrative Prognostic Value of Inflammatory Markers and KELIM Score in Ovarian Cancer Patients Treated With Neoadjuvant Chemotherapy.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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