Status:

RECRUITING

The Registry of Genetic Alterations of Taiwan Ovarian Cancer

Lead Sponsor:

National Health Research Institutes, Taiwan

Collaborating Sponsors:

National Taiwan University Hospital

Mackay Memorial Hospital

Conditions:

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Brief 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 se...

Detailed Description

Development of an integrated database of genetic background from treatment-naïve or recurrent populations, clinical information, and therapeutic outcomes in primary and recurrent ovarian cancer of hig...

Eligibility Criteria

Inclusion

  • Age 18 and above.
  • Stage I to IV high grade serous or clear cell carcinoma of ovary, peritoneal and fallopian tube.
  • Patients with primary ovarian cancer had undergone primary surgery. Patients with recurrent ovarian cancer had undergone primary surgery (and biopsy/surgery for recurrent tumors).
  • Tumor tissues before neoadjuvant therapy will be collected for patients receiving surgery after any neoadjuvant treatment.
  • Willingness to provide the surgical tissues of primary tumors, non-tumor part normal tissue (and paired recurrent tumors in 80 patients).
  • 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).
  • Patient fully understand the protocol with the willingness to have regular follow-up.
  • Life expectancy more than 3 months.

Exclusion

  • Concomitant ovarian and endometrial cancer
  • Paraffin tissue tumor block older than five years.
  • Tumor specimen of primary surgery or recurrent biopsy/surgery are not qualified for genetic testing.
  • Concomitant malignancy under surveillance or treatment in the past three years (excluding curatively treated basal or squamous cell skin carcinoma or carcinoma in situ)
  • Inability to cooperate or undesirable compliance to the study.

Key Trial Info

Start Date :

December 13 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2031

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT06127446

Start Date

December 13 2023

End Date

December 31 2031

Last Update

May 21 2025

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Chang Gung Medical Foundation

Kaohsiung City, Taiwan

2

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

3

China Medical University Hospital

Taichung, Taiwan

4

Taichung Veterans General Hospital

Taichung, Taiwan

The Registry of Genetic Alterations of Taiwan Ovarian Cancer | DecenTrialz