Where does OCRA's clinical trial data come from?

OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

How do I find clinical trials for ovarian cancer?

Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

How often is clinical trial data updated?

Trial data is refreshed through periodic ingestion from the ClinicalTrials.gov v2 API. Status changes, new enrollments, and newly registered trials are captured during each update cycle.

Cukurova Score Validation Study

NCT06378905RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Cukurova University

Enrollment

130

Start Date

2024-05-30

Completion Date

2026-03-01

Study Type

OBSERVATIONAL

Official Title

Cukurova Score Validation Study in Prediction of Primary Cytoreduction in Advanced Ovarian Cancer

Conditions

Epithelial Ovarian CancerPrimary Cytoreduction

Eligibility

Age Range

18 Years – 100 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Rate of complete cytoreduction

Complete cytoreduction (R0) is described as no visible residual tumor at the end of the surgery. The primary outcome of this study is to determine the rate of cases resulted with complete cytorection (R0).

Time frame: 1-3 years

Secondary Outcomes

Rate of postoperative 90-days mortality

Rate of cases died during 90 days after surgery

Time frame: postoperative 90 days during the study period

Locations

Cukurova University, Adana, Turkey (Türkiye)

Linked Papers

2024-01-05

The Cukurova score in the prediction of primary cytoreduction in ovarian cancer

Primary debulking surgery has been the preferred surgical route and is still considered a quality indicator for advanced ovarian cancer surgery. However, a significant number of patients are not amenable to upfront surgery. Neoadjuvant chemotherapy and interval debulking surgery may be the most suitable approach for this group. This study aimed to evaluate a novel score for prediction of the cytoreduction results at primary debulking surgery for ovarian cancer patients. This observational prospective study was conducted at a tertiary gynecologic oncology center between December 2020 and August 2022. Presumed primary stage III-IV epithelial ovarian carcinoma cases were included. Borderline tumors, and metastatic or non-epithelial ovarian malignancies, were excluded. Based on imaging findings, points were assigned to each anticipated surgical procedure required for complete cytoreduction. The sum of these points was multiplied by the patient's Eastern Cooperative Oncology Group (ECOG) score, and thus, the Cukurova-clinic score was established. Furthermore, the required surgical procedures based on laparoscopic evaluation were recorded, and the score was readjusted and calculated to obtain the Cukurova score. One hundred and fourteen patients were included in the study. Primary debulking surgery was performed in 70% of cases. Among them, complete cytoreduction (Cukurova score ≤12) was obtained in 97.3% of cases. Complete cytoreduction was not achieved in cases with Cukurova score >12. The odds ratio of 90-day mortality was 13.4 for patients with Cukurova score >12, compared with those with Cukurova score ≤12. The Cukurova score is a model for classifying advanced ovarian cancer patients who may be candidates for primary debulking surgery.

Linked Investigators

Ghanim Khatib

Sevtap Seyfettinoglu

Umran Kucukgoz Gulec