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Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer

NCT05523804UNKNOWNOBSERVATIONAL

Summary

To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer.

Key Facts

Lead Sponsor

NHS Grampian

Enrollment

800

Start Date

2022-08-26

Completion Date

2023-12-31

Study Type

OBSERVATIONAL

Official Title

Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer: A GO SOAR Led Study (GO SOAR2)

Interventions

interval cytoreductive surgerydelayed cytoreductive surgeryno surgery

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

Women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (\>5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (\>5 cycles of chemotherapy alone.

Exclusion Criteria:

Women undergoing recurrent cytoreductive surgery.

Outcome Measures

Primary Outcomes

overall survival

defined from date of diagnosis to date of death by any cause or loss to follow-up

Time frame: 15 years

progression free survival

defined from date of diagnosis to date of first recurrence

Time frame: 15 years

facilitator/barriers to access to cytoreductive surgery

topic guide interview questionnaire to be used to elicit factors aiding/preventing access to cytoreductive surgery internationally

Time frame: 15 years

Secondary Outcomes

Post-operative morbidity

as per Clavien-Dindo classification

Time frame: within 30 days from date of surgery

Resectability rates

R0 = no visible disease, R1 = \<10mm visible residual disease, R2 = \>10mm visible residual disease

Time frame: at time of surgery

Locations

The Royal London Hospital, London, United Kingdom

Linked Papers

2022-12-05

Patient outcomes following interval and delayed cytoreductive surgery in advanced ovarian cancer: protocol for a multicenter, international, cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative)

The Global Gynecological Oncology Surgical Outcomes Collaborative (GO SOAR) has developed a network of gynecological oncology surgeons, surgical departments, and other interested parties that have the long-term ability to collaborate on outcome studies. Presented is the protocol for the GO SOAR2 study. To compare survival following interval and delayed cytoreductive surgery, between delayed cytoreductive surgery and no surgery (chemotherapy alone); and international variations in access to cytoreductive surgery for women with stage III-IV epithelial ovarian cancer. There is no difference in survival following interval and delayed cytoreductive surgery; there is poorer survival with no surgery compared with delayed cytoreductive surgery; and there are international disparities in prevalent practice and access to cytoreductive surgery in women with stage III-IV epithelial ovarian cancer. International, multicenter, mixed-methods cohort study. Participating centers, will review medical charts/electronic records of patients who had been consecutively diagnosed with stage III-IV ovarian cancer between January 1, 2006 and December 31, 2021. Qualitative interviews will be conducted to identify factors determining international variations in prevalent practice and access to cytoreductive surgery. Inclusion criteria include women with stage III-IV epithelial ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (≥5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (≥5 cycles of chemotherapy alone). Overall survival (defined from date of diagnosis to date of death); progression-free survival (defined from date of diagnosis to date of first recurrence); facilitator/barriers to prevalent practice and access to cytoreductive surgery. In order to determine whether there is a difference in survival following interval and delayed cytoreductive surgery and no surgery, data will be abstracted from 1000 patients. It is estimated that recruitment will be completed by 2023, and results published by 2024. NCT05523804.

Linked Investigators

Faiza Gaba

Ioannis C Kotsopoulos

Nicolò Bizzarri

Pedro T Ramirez