| NCT ID | NCT06378905 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cukurova University |
| Condition | Epithelial Ovarian Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-05-30 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2024-05-30 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 18 years old and over * Suspected advanced ovarian/fallopian tube/ primary peritoneal carcinomatosis on imaging * Pathologically confirmed Stage III-IV epithelial ovarian cancer/fallopian tube/ primary peritoneal carcinomatosis * Consent to participate in the study Exclusion Criteria: * Stage I-II epithelial ovarian/fallopian tube/peritoneal cancer * Nonepithelial Ovarian Cancer * Benign Ovarian tumors * Borderline Ovarian Tumors * Metastatic Ovarian Tumors * Rejecting to Participate in the Study * \<18 years old
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06378905 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Epithelial Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06378905 currently recruiting?
Yes, NCT06378905 is actively recruiting participants. Contact the research team at ghanim.khatib@gmail.com for enrollment information.
Where is the NCT06378905 trial being conducted?
This trial is being conducted at Adana, Turkey (Türkiye).
Who is sponsoring the NCT06378905 clinical trial?
NCT06378905 is sponsored by Cukurova University. The trial plans to enroll 130 participants.
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