The Registry of Genetic Alterations of Taiwan Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

The Registry of Genetic Alterations of Taiwan Ovarian Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127446
• Other study ID #: T1E23
• Status: Not yet recruiting
• Start date: November 15, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: National Health Research Institutes, Taiwan
• Contact: Ya-Ling Wu
• Phone: 86-3-7206166
• Email: yalin[@]nhri.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Description:

Development of an integrated database of genetic background from treatment-naïve or platinum-refractory populations, clinical information, and therapeutic outcomes in primary and recurrent ovarian cancer of high grade serous or clear cell adenocarcinoma.

1. To enroll 280 patients who fit the criteria of this study in the enrolled period.

2. To perform large-scale NGS analysis including 440 cancer gene panel and 24 HRD panel for specific populations, to create a map containing important genetic characteristics to help understand the mechanisms of drug resistance, and to find novel treatment strategies.

3. To collect tumor, non-tumor normal tissues and/or blood sample for genetic study (including NGS, whole-exome sequencing, RNA sequencing), proteomic study (including phosphoprotein), human leukocyte antigen testing, neoantigen and biomarker analyses.

4. To record previous therapeutic agents and accompanying treatment response and adverse events

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 and above.

2. Stage II to IV high grade serous or clear cell ovarian cancer

3. Patients with primary ovarian cancer had undergone primary surgery.

4. Patients with platinum-resistant recurrent ovarian cancer (<180 days after platinum-based therapy) had undergone primary surgery (and biopsy/surgery for recurrent tumors).

5. Willingness to provide the surgical tissues of primary tumors, non-tumor part normal tissue (and paired platinum-resistant recurrent tumors in 100 patients). Non-tumor part normal ovary tissue will be collected along with at least 190 primary or recurrent tumor specimens.

6. Willingness to provide blood sample of 20ml within two weeks after registration (in at least 72 patients of primary ovarian cancer and 152 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. Patients who had neoadjuvant therapy for newly diagnosed ovarian cancer.

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

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

Sponsors (9)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Cathay General Hospital, Chang Gung Medical Foundation, China Medical University Hospital, Kaohsiung Veterans General Hospital., Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Large-scale NGS analysis for specific populations	Development of an integrated database of genetic background from treatment-naïve or platinum-refractory populations, clinical information, and therapeutic outcomes in primary and recurrent ovarian cancer of high grade serous or clear cell adenocarcinoma.	2023/10~2028/12