The Registry of Genetic Alterations of Taiwan Ovarian Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-13

Study Completion Date

2031-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ovarian Clear Cell Adenocarcinoma Review

NCT02129036

Ovarian Cysts

COMPLETED

Development and Validation of an Ovarian Cancer Risk Prediction Model for Family Members of Ovarian Cancer Probands

NCT07039552

Hereditary Breast and Ovarian Cancer Syndrome BRCA Mutations

RECRUITING

Factors Affecting the Prognosis of Early Ovarian Cancer

NCT04414683

Ovarian Cancer

UNKNOWN

Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation

NCT05763472

BRCA-Associated Breast Carcinoma

UNKNOWN

BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary

NCT06304922

Ovarian Cancer

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No