Cukurova Score Validation Study
NCT06378905 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130
Last updated 2024-08-29
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
More Related Trials
-
Biomarkers in Predicting Response in Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Treated on GOG-0172 or GOG-0182
NCT01074398 ·Status: UNKNOWN
-
New Biomarkers Evaluating Ovarian Cancer
NCT01466049 ·Status: COMPLETED
-
Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer
NCT04752865 ·Status: UNKNOWN
-
DOD Long-Term Survivors of Ovarian Cancer
NCT02321735 ·Status: UNKNOWN ·Phase: NA
-
Women Surviving Ovarian Cancer
NCT00596349 ·Status: COMPLETED
-
SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery
NCT06223763 ·Status: RECRUITING
-
Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test
NCT06366997 ·Status: COMPLETED
-
Genomic Profiling of the Residual Disease of Advanced-stage Ovarian Cancer After Neoadjuvant Chemotherapy
NCT03491033 ·Status: COMPLETED
-
A Study of Second Look Laparoscopy (SLL) in People With Ovarian Cancer Who Have Completed Their First Course of Chemotherapy
NCT06240598 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Development and Validation of a Prediction Model for AKI Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer
NCT06697613 ·Status: COMPLETED
-
Long Term Survivors in Ovarian Cancer
NCT03128294 ·Status: TERMINATED
-
Study of the Impact on Survival of a Paradigm Shift in the Therapeutic Strategy of Patients With Advanced Ovarian Cancer
NCT06907771 ·Status: RECRUITING
-
Multi-layer Data to Improve Diagnosis, Predict Therapy Resistance and Suggest Targeted Therapies in HGSOC
NCT04846933 ·Status: RECRUITING ·Phase: NA
-
A Cohort Establishment Study of Total Management of Ovarian Cancer
NCT06018935 ·Status: RECRUITING
-
Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma
NCT06969833 ·Status: RECRUITING ·Phase: NA
-
Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases
NCT01048814 ·Status: COMPLETED
-
A Non-interventional Prospective Study of 1-st Line Treatment Approaches in OVArian Cancer Patients With HRD+ Status in Russian Federation
NCT05918042 ·Status: COMPLETED
-
Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype
NCT05574673 ·Status: RECRUITING
-
New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer
NCT06120309 ·Status: ENROLLING_BY_INVITATION
-
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer
NCT04257786 ·Status: UNKNOWN ·Phase: NA
-
Pathway to Diagnosis of Ovarian Cancer
NCT01061619 ·Status: UNKNOWN
-
Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
NCT01295489 ·Status: COMPLETED
-
Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer
NCT05236686 ·Status: RECRUITING ·Phase: NA
-
Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer
NCT03656809 ·Status: COMPLETED
-
The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Ovarian Cancer
NCT02856841 ·Status: COMPLETED