RecruitingNCT06127446

The Registry of Genetic Alterations of Taiwan Ovarian Cancer


Sponsor

National Health Research Institutes, Taiwan

Enrollment

300 participants

Start Date

Dec 13, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study is collecting tumor and blood samples from women in Taiwan with high-grade serous or clear cell ovarian, fallopian tube, or peritoneal cancer to study the genetic changes in these tumors and improve understanding and treatment of this disease. **You may be eligible if:** - You are 18 or older - You have been diagnosed with Stage I–IV high-grade serous or clear cell ovarian, peritoneal, or fallopian tube cancer - You have had primary surgery (and biopsy/surgery for recurrent tumors, if applicable) - You are willing to donate tumor tissue and a 20 mL blood sample - Your life expectancy is more than 3 months **You may NOT be eligible if:** - You have both ovarian and endometrial cancer at the same time - Your tumor tissue block is older than 5 years - Your tumor sample is not suitable for genetic testing - You have another active cancer being treated or monitored (diagnosed within the past 3 years, except for certain skin cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(8)

Chang Gung Medical Foundation

Kaohsiung City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Cathay General Hospital

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

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NCT06127446


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