Cukurova Score Validation Study

NCT06378905 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2024-08-29

No results posted yet for this study

Summary

Despite significant advancements in imaging technologies, surgical techniques, chemotherapeutic regimens, and treatment strategies in recent years, ovarian cancer continues to remain the most deadly gynecological malignancy. Approximately 90% of ovarian cancers originate from the coelomic epithelium or modified mesothelial cells and are classified as epithelial ovarian cancers. The majority of patients with epithelial ovarian cancer (70-80%) present in advanced stages. The primary treatment for advanced-stage (stage 3-4) disease consists of primary cytoreductive surgery followed by adjuvant chemotherapy. Cytoreductive surgery aims to remove all visible tumor implants regardless of the extent of the disease and achieve no visible residual tumor (complete cytoreduction, R0) at the end of the surgery. In cases where R0 cannot be achieved (due to poor general condition and/or extensive tumor that cannot be completely excised surgically), the option of neoadjuvant chemotherapy followed by interval cytoreductive surgery is considered. Primary cytoreductive surgery is still the preferred option and is considered a quality indicator for centers performing advanced-stage ovarian cancer surgeries. Despite advancements in surgery, the decision for interval surgery following primary surgery or neoadjuvant chemotherapy is often based on the surgeon's experience, imaging results, and clinic preferences. Various methods and scores have been published and applied to predict which patients are suitable for primary surgery.

The Cukurova score developed in our clinic conceptualizes prioritizing surgical procedures using radiological imaging and diagnostic exploratory laparoscopy to achieve complete cytoreduction in harmony with the patient's clinical and performance status, rather than focusing solely on tumor burden. The score showed high success rates for complete cytoreduction and also was useful in terms of predicting the morbidity and mortality. However, the Cukurova score study was conducted in single center. Validation of scores in centers with different capacities is expected to facilitate their widespread use and acceptance. Therefore, in this study, the investigators plan to conduct a validation study of the score in a total of 20 centers in Turkey, including our center. This study aims to evaluate the validity of the Cukurova score in predicting outcomes of primary cytoreduction in advanced ovarian cancer patients and thus determining the decision for primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery.

Conditions

  • Epithelial Ovarian Cancer
  • Primary Cytoreduction

Sponsors & Collaborators

  • Muğla Sıtkı Koçman University

    collaborator OTHER
  • Sakarya University

    collaborator OTHER
  • Gazi University

    collaborator OTHER
  • Ankara Etlik City Hospital

    collaborator OTHER_GOV
  • Kayseri City Hospital

    collaborator OTHER_GOV
  • Mersin University

    collaborator OTHER
  • Selçuk University

    collaborator UNKNOWN
  • Bezmialem Vakif University

    collaborator OTHER
  • Uludag University

    collaborator OTHER
  • Mersin City Hospital

    collaborator UNKNOWN
  • Marmara University

    collaborator OTHER
  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    collaborator OTHER
  • Ankara University

    collaborator OTHER
  • Ege University

    collaborator OTHER
  • Hacettepe University

    collaborator OTHER
  • Akdeniz University

    collaborator OTHER
  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    collaborator OTHER
  • Mustafa Kemal University

    collaborator OTHER
  • Trakya University

    collaborator OTHER
  • Cukurova University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2026-03-31
Completion
2027-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06378905 on ClinicalTrials.gov