Registry of genetic changes in ovarian cancer in Taiwan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.