Ovarian CancerNCT05255861
An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy
An observational study of Ovarian Cancer, run by Xin Wu at 1 site in China.
Trial summary
This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Chinese women with ovarian cancer
Who may be able to join
- age ≥ 18 years;
- high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
- FIGO stage III or IV;
- at least 6 cycles and no more than 9 cycles First-line platinum-containing chemotherapy;
- CR or PR after chemotherapy;
- ECOG 0-1;
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- sufficient biological samples for HRD score detection;
- patients signed informed consent;
- good bone marrow function.
Who cannot join
- incomplete follow-up records of survival information;
- unqualified biological sample quality control
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Xin Wu, PHD, (021)33189900-6529, wuxin_fc@fudan.edu.cn
About this study
This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm suitable for the Chinese population, so as to provide evidence for the role of PARPi in ovarian cancer. The screening of the beneficiaries of maintenance therapy provides precise guidance and can be used as a reference for other cancer types.
- Conditions
- Ovarian Cancer
- Keywords
- Homologous Recombination Deficiency Score
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Homologous Recombination Deficiency score
Optimize the Homologous Recombination Deficiency scoring algorithm to calculate the Homologous Recombination Deficiency score of each patient's ovarian cancer tissue
Measured: After the ovarian tissue is obtained, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2024 (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
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Wu, Obstetrics & Gynecology Hospital of Fudan University
- Investigators
- Xin Wu, PHD, Principal investigator, The Obstetrics and Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255861
- Sponsor's protocol ID
- FUOBGY2021-246
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy
- ClinicalTrials.gov ID
- NCT05255861
- Acronym / sponsor ID
- FUOBGY2021-246
- Conditions
- Ovarian Cancer
- Keywords
- Homologous Recombination Deficiency Score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xin WuUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Feb 2022 (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.
This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm suitable for the Chinese population, so as to provide evidence for the role of PARPi in ovarian cancer. The screening of the beneficiaries of maintenance therapy provides precise guidance and can be used as a reference for other cancer types.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese women with ovarian cancer
Key inclusion criteria (9 listed)
- age ≥ 18 years;
- high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
- FIGO stage III or IV;
- at least 6 cycles and no more than 9 cycles First-line platinum-containing chemotherapy;
- CR or PR after chemotherapy;
Key exclusion criteria (2 listed)
- incomplete follow-up records of survival information;
- unqualified biological sample quality control
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
Homologous Recombination Deficiency score
Time frame: After the ovarian tissue is obtained, an average of 3 year
Optimize the Homologous Recombination Deficiency scoring algorithm to calculate the Homologous Recombination Deficiency score of each patient's ovarian cancer tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xin Wu, PHD principal investigator
The Obstetrics and Gynecology Hospital of Fudan University
1 site 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 Xin Wu at 1 site in China.
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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Wu, PHD ((021)33189900-6529, wuxin_fc@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homologous Recombination Deficiency score (time frame: After the ovarian tissue is obtained, an average of 3 year). 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 25 Feb 2022.