Ovarian CancerNCT06490380
HRD Status Reference Standard Based on WGS
An observational study of Ovarian Cancer, run by Lei Li at 1 site in China.
Trial summary
When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- PARPi
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2022to 21 Jun 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Ovarian cancer patients received first-line PARPi maintenance therapy
Who may be able to join
- At least 18 years of age at diagnosis
- Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- High-grade serous or high-grade endometroid histological type
- FIGO stage II, III, or IV
- Complete response or partial response following completion of first-line adjuvant chemotherapy
- PARPi administered as first-line maintenance therapy
Who cannot join
- First-line surgery not conducted
- Total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5
- First-line PARPi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy
- Genotyping quality-control failed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing
When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.
Read the detailed description
- Primary objective: To establish a HRD status reference standard based on WGS.
- Secondary objective: To validate the analytical performance of panel HRD status using WGS HRD status as reference standard.
- Exploratory objective 1: To explore how methylation of selective genes correlate with WGS HRD status and efficacy.
- Exploratory objective 2: To explore how HRR gene mutations correlate with WGS HRD status and efficacy.
- Exploratory objective 3: To set up a harmonized bioinformatic analysis workflow for WGS HRD status.
- Conditions
- Ovarian Cancer
- Being tested
- PARPi
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARPiDrug
Poly(adenosine diphosphate-ribose) polymerase inhibitor (PARPi)
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time from first dose of PARPi to disease progression or death, whichever occurs first.
Measured: Up to 42 months
Secondary outcomes (1)
Overall survival
Time from first dose of PARPi to death.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start30 Dec 2022
- Primary completion13 Dec 2023
- Study completion21 Jun 2024
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes for Food and Drug Control, China, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490380
- Sponsor's protocol ID
- HRDref-WGS
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing
- ClinicalTrials.gov ID
- NCT06490380
- Acronym / sponsor ID
- HRDref-WGS
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Collaborators
- National Institutes for Food and Drug Control, China, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 8 Jul 2024 (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.
When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.
Detailed description
- Primary objective: To establish a HRD status reference standard based on WGS.
- Secondary objective: To validate the analytical performance of panel HRD status using WGS HRD status as reference standard.
- Exploratory objective 1: To explore how methylation of selective genes correlate with WGS HRD status and efficacy.
- Exploratory objective 2: To explore how HRR gene mutations correlate with WGS HRD status and efficacy.
- Exploratory objective 3: To set up a harmonized bioinformatic analysis workflow for WGS HRD status.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ovarian cancer patients received first-line PARPi maintenance therapy
Key inclusion criteria (6 listed)
- At least 18 years of age at diagnosis
- Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- High-grade serous or high-grade endometroid histological type
- FIGO stage II, III, or IV
- Complete response or partial response following completion of first-line adjuvant chemotherapy
Key exclusion criteria (4 listed)
- First-line surgery not conducted
- Total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5
- First-line PARPi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy
- Genotyping quality-control failed
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 |
|---|---|---|
| PARPiPoly(adenosine diphosphate-ribose) polymerase inhibitor (PARPi) | Drug | – |
Primary outcome
Progression-free survival
Time frame: Up to 42 months
Time from first dose of PARPi to disease progression or death, whichever occurs first.
1 secondary outcome
Overall survival
Time frame: Up to 48 months
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 8 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 6 inclusion and 4 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 8 Jul 2024. 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?
Progression-free survival (time frame: Up to 42 months). 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 8 Jul 2024.