Trial Title:
The Registry of Genetic Alterations of Taiwan Ovarian Cancer
NCT ID:
NCT06127446
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
ovarian cancer
Next generation sequencing
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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 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.
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 high grade serous or clear cell adenocarcinoma.
1. To enroll 300 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
Criteria for eligibility:
Study pop:
Stage I to IV high grade serous or clear cell ovarian cancer
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Gender based:
Yes
Gender description:
Ovarian cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chang Gung Medical Foundation
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Kaohsiung Veterans General Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Cathay General Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Mackay Memorial Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Start date:
December 13, 2023
Completion date:
December 31, 2030
Lead sponsor:
Agency:
National Health Research Institutes, Taiwan
Agency class:
Other
Collaborator:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
Mackay Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
Cathay General Hospital
Agency class:
Other
Collaborator:
Agency:
China Medical University Hospital
Agency class:
Other
Collaborator:
Agency:
Taichung Veterans General Hospital
Agency class:
Other
Collaborator:
Agency:
National Cheng-Kung University Hospital
Agency class:
Other
Collaborator:
Agency:
Chang Gung Medical Foundation
Agency class:
Other
Collaborator:
Agency:
Kaohsiung Veterans General Hospital.
Agency class:
Other
Source:
National Health Research Institutes, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06127446
