Epithelial Ovarian CancerNCT04651920
A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer
An observational study of Epithelial Ovarian Cancer and Chinese, run by Lei Li at 1 site in China.
Trial summary
The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Chinese, Homologous Recombination Deficiency
- What is being tested?
- Evaluation of homologous recombination deficiency score
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2020to 26 Mar 2022
- 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 years and older
- Women only
- Adult, Older adult
Study population: Chinese population with confirmed diagnosis of epithelial ovarian cancer with known targeted gene mutations via a multi-panel testing of 27 genes and known resistance to platinum-based chemotherapy
Who may be able to join
- Aged 18 years or older
- Pathological confirmation of epithelial ovarian cancer
- With available tumor tissues
- Given consents to participate the study
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on Association Between Homologous Recombination Genes and the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer
The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. This study would recruit 400 Chinese EOC patients with known targeted gene mutations via a multi-panel testing of 27 genes, including BRCA1/BRCA2. All patients accept evaluation of HRD model, which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.
- Conditions
- Epithelial Ovarian Cancer, Chinese, Homologous Recombination Deficiency, BRCA1 Mutation, BRCA2 Mutation, Prognosis
- Being tested
- Evaluation of homologous recombination deficiency score
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of homologous recombination deficiency scoreGenetic
Evaluation of homologous recombination deficiency score which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST)
| Study group | Role | What they receive |
|---|---|---|
| Epithelial ovarian cancer patients sensitive to platinum based chemotherapy | Not described Receives: Genetic: Evaluation of homologous recombination deficiency score | |
| Epithelial ovarian cancer patients resistant to platinum based chemotherapy | Not described Receives: Genetic: Evaluation of homologous recombination deficiency score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homologous recombination deficiency (HRD) score
The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for three types of important molecular mechanism: loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor.
Measured: Two years
Secondary outcomes (2)
Progression-free survival
Progression-free survival in recruited patients
Measured: Five years
Overall survival
Overall survival in recruited patients
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start26 Nov 2020
- Primary completion26 Mar 2022
- Study completion26 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651920
- Sponsor's protocol ID
- EOC-HRD2
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Association Between Homologous Recombination Genes and the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04651920
- Acronym / sponsor ID
- EOC-HRD2
- Conditions
- Epithelial Ovarian Cancer, Chinese, Homologous Recombination Deficiency, BRCA1 Mutation, BRCA2 Mutation, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 3 Dec 2020 (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.
The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. This study would recruit 400 Chinese EOC patients with known targeted gene mutations via a multi-panel testing of 27 genes, including BRCA1/BRCA2. All patients accept evaluation of HRD model, which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epithelial ovarian cancer patients sensitive to platinum based chemotherapy | – | Genetic: Evaluation of homologous recombination deficiency score |
| Epithelial ovarian cancer patients resistant to platinum based chemotherapy | – | Genetic: Evaluation of homologous recombination deficiency score |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Chinese population with confirmed diagnosis of epithelial ovarian cancer with known targeted gene mutations via a multi-panel testing of 27 genes and known resistance to platinum-based chemotherapy
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Pathological confirmation of epithelial ovarian cancer
- With available tumor tissues
- Given consents to participate the study
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of homologous recombination deficiency scoreEvaluation of homologous recombination deficiency score which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST) | Genetic | Epithelial ovarian cancer patients resistant to platinum based chemotherapy, Epithelial ovarian cancer patients sensitive to platinum based chemotherapy |
Primary outcome
Homologous recombination deficiency (HRD) score
Time frame: Two years
The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for three types of important molecular mechanism: loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor.
2 secondary outcomes
Progression-free survival
Time frame: Five years
Overall survival
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
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 Epithelial Ovarian Cancer and Chinese, run by Lei Li 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 29 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homologous recombination deficiency (HRD) score (time frame: Two years). 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 29 Mar 2022; AzTrials last refreshed its copy on 26 Oct 2026.