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The Registry of Genetic Alterations of Taiwan Ovarian Cancer

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Primary and study completion dates: Dec 31, 2030 to Dec 31, 2031v3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary and study completion dates: Dec 31, 2028 to Dec 31, 2030
    • Enrollment target: 280 to 300
    • Start date changed from estimate of Nov 15, 2023 to Dec 13, 2023
    • Eligibility criteria shortened, about 6 words
    • Study description revised
    • Site details revised at 8 of 8 sites
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Despite recent progress in chemotherapy and targeted therapy for ovarian cancer, the 5-year survival rate remains around 40% because of rapid development of treatment resistance and recurrence. The sensitivity to platinum agents or BRCA genes mutation has been the prerequisite for improved survival using PARP inhibitors, though only 15-20% ovarian cancer patients harbor BRCA mutations through germline or somatic variants. Bevacizumab can only delayed disease recurrence but failed to improve overall survival. Several approved cancer therapeutics with established safety and toxicity profiles should be assessed in the immediate future based on biomarkers of platinum resistant, BRCA wild type recurrent ovarian cancer. Furthermore, the proportion high grade serous and clear cell adenocarcinoma of ovary cancer in Taiwan increased substantially in recent 10 years. Genetic factors (such as homologous recombination deficiency, mismatch repair genes mutation), environmental factors (such as oral contraceptives, nulliparity/low parity) as well as comorbidity including endometriosis may be associated with the changing pattern and clinical outcomes of ovarian cancer in Taiwan. Next-generation sequencing technology has enabled cancer genome sequencing in screening and searching for new cancer genes in an efficient manner. This massive sequencing technique not only help to identify new altered genes for novel biomarker development, but also reveal gene alterations sensitive or resistant to specific therapies. The specific aims of this project are (1) to systemically explore genomic profiling of Taiwanese primary or platinum-resistant or -sensitive recurrent (or recurrent) ovarian cancer focusing on high grade serous and clear cell adenocarcinoma; (2) to collect clinical data regarding comorbidity, survival time and responses to major types of anticancer therapy; and (3) to establish a comprehensive ovarian cancer cohort for additional translational studies. The long-term goals of this study are to help implement personalized therapy, to develop novel therapy, and to improve outcomes of patients with ovarian cancer.
Trial Details
NCT Number NCT06127446
Lead Sponsor National Health Research Institutes, Taiwan
Collaborators: National Taiwan University Hospital, Mackay Memorial Hospital, Cathay General Hospital, China Medical University Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Medical Foundation, Kaohsiung Veterans General Hospital.
Conditions
(from sponsor)
Ovarian Cancer
Related terms Ovarian Neoplasms
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov