Registry of genetic changes in ovarian cancer in Taiwan
The Registry of Genetic Alterations of Taiwan Ovarian Cancer
This study is trying to gather genetic information from women with advanced ovarian cancer in Taiwan to see how it affects treatment responses and to find new ways to improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Health Research Institutes, Taiwan Academic / other |
| Drugs / interventions | Bevacizumab, chemotherapy |
| Locations | 8 sites (Kaohsiung City and 7 other locations) |
| Trial ID | NCT06127446 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a comprehensive database of genetic alterations and clinical outcomes in patients with high grade serous or clear cell ovarian cancer in Taiwan. It will enroll 300 patients, collecting tumor and blood samples for extensive genetic analysis using next-generation sequencing (NGS) and other methodologies. The goal is to understand the mechanisms of drug resistance and identify potential novel treatment strategies based on genetic profiles. The study will also document previous treatments and their responses to better inform future therapeutic approaches.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above with stage I to IV high grade serous or clear cell carcinoma of the ovary, peritoneum, or fallopian tube.
Not a fit: Patients with concomitant ovarian and endometrial cancer or those without available tumor tissue samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for ovarian cancer patients, particularly those with drug-resistant forms of the disease.
How similar studies have performed: Other studies utilizing genetic profiling in ovarian cancer have shown promise, suggesting that this approach could yield valuable insights and advancements in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kaohsiung City and 7 other locations
- 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)
Study contacts
- Principal investigator: Hui-Ju Ch'ang — National Health Research Institutes, Taiwan
- Study coordinator: Ya-Ling Wu
- Email: yalin@nhri.edu.tw
- Phone: 86-3-7206166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.