Epithelial Ovarian CancerNCT04651933
A Training Set for the HRD Model in EOC
An observational study of Epithelial Ovarian Cancer and BRCA Mutation, run by Lei Li at 1 site in China.
Trial summary
A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, BRCA Mutation, Loss of Heterozygosity
- What is being tested?
- Homologous recombination deficiency model
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2020to 26 Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known BRCA1/2 mutation status and 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.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 8613911988831, lileigh@163.com
About this study
Official title: A Training Set for the Homologous Recombination Deficiency Scoring Model With Loss of Heterozygosity Status in Epithelial Ovarian Cancer
A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. 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, BRCA Mutation, Loss of Heterozygosity, Prognosis, Platinum Resistance, Homologous Recombination Deficiency
- Being tested
- Homologous recombination deficiency model
- 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.
Homologous recombination deficiency modelGenetic
A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH)
| Study group | Role | What they receive |
|---|---|---|
| Epithelial ovarian cancer patients sensitive to platinum based chemotherapy | Not described Receives: Genetic: Homologous recombination deficiency model | |
| Epithelial ovarian cancer patients resistant to platinum based chemotherapy | Not described Receives: Genetic: Homologous recombination deficiency model |
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 loss of heterozygosity (LOH), and 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 Nov 2022 (estimated)
- Study completion26 Nov 2022 (estimated)
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
- 200 participants (estimated)
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
- NCT04651933
- Sponsor's protocol ID
- EOC-LOH
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 4 Dec 2020
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Training Set for the Homologous Recombination Deficiency Scoring Model With Loss of Heterozygosity Status in Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04651933
- Acronym / sponsor ID
- EOC-LOH
- Conditions
- Epithelial Ovarian Cancer, BRCA Mutation, Loss of Heterozygosity, Prognosis, Platinum Resistance, Homologous Recombination Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 26 Nov 2022 (estimated)
- Study completion
- 26 Nov 2022 (estimated)
- 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.
A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. 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: Homologous recombination deficiency model |
| Epithelial ovarian cancer patients resistant to platinum based chemotherapy | – | Genetic: Homologous recombination deficiency model |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known BRCA1/2 mutation status and 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 |
|---|---|---|
| Homologous recombination deficiency modelA homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) | 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 loss of heterozygosity (LOH), and 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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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 BRCA Mutation, 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: status not confirmed, as of the sponsor's last update on 4 Dec 2020. 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 Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. 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 4 Dec 2020; AzTrials last refreshed its copy on 27 Oct 2026.