The Registry of Genetic Alterations of Taiwan Ovarian Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNational Health Research Institutes, Taiwan

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

National Health Research Institutes, Taiwan

Lead sponsor

National Taiwan University Hospital

Collaborator

Mackay Memorial Hospital

Collaborator

Cathay General Hospital

Collaborator

China Medical University Hospital

Collaborator

Taichung Veterans General Hospital

Collaborator

National Cheng-Kung University Hospital

Collaborator

Chang Gung Medical Foundation

Collaborator

Kaohsiung Veterans General Hospital.

Collaborator