Ovarian CancerNCT06127446
The Registry of Genetic Alterations of Taiwan Ovarian Cancer
An observational study of Ovarian Cancer, run by National Health Research Institutes, Taiwan at 8 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 300 participants
- Where
- 8 sitesTaiwan
- Study dates
- 13 Dec 2023to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Stage I to IV high grade serous or clear cell ovarian cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Taiwan8 sites, 8 recruiting
- Recruiting
Chang Gung Medical Foundation
Kaohsiung City
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City
- Recruiting
China Medical University Hospital
Taichung
- Recruiting
Taichung Veterans General Hospital
Taichung
- Recruiting
National Cheng Kung University Hospital
Tainan
- Recruiting
Cathay General Hospital
Taipei
- Recruiting
Mackay Memorial Hospital
Taipei
- Recruiting
National Taiwan University Hospital
Taipei
About this study
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.
Read more
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.
Read the 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.
- To enroll 300 patients who fit the criteria of this study in the enrolled period.
- 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.
- 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.
- To record previous therapeutic agents and accompanying treatment response and adverse events
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, Next generation sequencing
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2023/10~2028/12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start13 Dec 2023
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, Cathay General Hospital, China Medical University Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Medical Foundation, Kaohsiung Veterans General Hospital.
- Responsible party
- Sponsor
- Investigators
- Hui-Ju Ch'ang, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127446
- Sponsor's protocol ID
- T1E23
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Registry of Genetic Alterations of Taiwan Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06127446
- Acronym / sponsor ID
- T1E23
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, Next generation sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, Cathay General Hospital, China Medical University Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Medical Foundation, Kaohsiung Veterans General Hospital.
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- To enroll 300 patients who fit the criteria of this study in the enrolled period.
- 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.
- 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.
- To record previous therapeutic agents and accompanying treatment response and adverse events
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage I to IV high grade serous or clear cell ovarian cancer
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Large-scale NGS analysis for specific populations
Time frame: 2023/10~2028/12
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui-Ju Ch'ang principal investigator
National Health Research Institutes, Taiwan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by National Health Research Institutes, Taiwan at 8 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ya-Ling Wu (86-3-7206166 ext. 35119, yalin@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large-scale NGS analysis for specific populations (time frame: 2023/10~2028/12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.