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Clinical Trials in China / NCT06127446
Recruiting Observational

The Registry of Genetic Alterations of Taiwan Ovarian Cancer

NCT06127446 · tracked via the Priya Life Science China tracker
Sponsor
National Health Research Institutes, Taiwan
Phase
Observational
Started
2023-12-13
Last updated
2026-04-09

Condition(s) studied

Ovarian Cancer

Study 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
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 and above. 2. Stage I to IV high grade serous or clear cell carcinoma of ovary, peritoneal and fallopian tube. 3. Patients with primary ovarian cancer had undergone primary surgery. Patients with recurrent ovarian cancer had undergone primary surgery (and biopsy/surgery for recurrent tumors). 4. Tumor tissues before neoadjuvant therapy will be collected for patients receiving surgery after any neoadjuvant treatment. 5. Willingness to provide the surgical tissues of primary tumors, non-tumor part normal tissue (and paired recurrent tumors in 80 patients). 6. Willingness to provide blood sample of 20ml within four weeks after registration (in at least 72 patients of primary ovarian cancer and 72 patients of recurrent ovarian cancer). 7. Patient fully understand the protocol with the willingness to have regular follow-up. 8. Life expectancy more than 3 months. Exclusion Criteria: 1. Concomitant ovarian and endometrial cancer 2. Paraffin tissue tumor block older than five years. 3. Tumor specimen of primary surgery or recurrent biopsy/surgery are not qualified for genetic testing. 4. Concomitant malignancy under surveillance or treatment in the past three years (excluding curatively treated basal or squamous cell skin carcinoma or carcinoma in situ) 5. Inability to cooperate or undesirable compliance to the study.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Chang Gung Medical Foundation Kaohsiung City Taiwan Recruiting
Kaohsiung Veterans General Hospital Kaohsiung City Taiwan Recruiting
China Medical University Hospital Taichung Taiwan Recruiting
Taichung Veterans General Hospital Taichung Taiwan Recruiting
National Cheng Kung University Hospital Tainan Taiwan Recruiting
Cathay General Hospital Taipei Taiwan Recruiting
Mackay Memorial Hospital Taipei Taiwan Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting

More National Health Research Institutes, Taiwan trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06127446 on ClinicalTrials.gov ↗ ← All trials in China