Ovarian CancerHOPEIINCT05069818
Variance of HRD From Paired Ovarian Cancer
An observational study of Ovarian Cancer and HRD, run by Xiaoxiang Chen at 1 site in China.
Trial summary
Homologous recombination deficiency (HRD) is an important biomarker of poly (ADP-ribose) polymerase inhibitor (PARPi) in patients with high-grade serous ovarian cancer (HGSOC). The stability of HRD in the recurrent HGSOC and its primary pair remains unknown. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, HRD, Platinum-sensitive Ovarian Cancer
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Dec 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: Platinum-sensitive relapsed high-grade serous ovarian cancer patients undergoing secondary cytoreductive surgery
Who may be able to join
- Subjects join the study voluntarily and sign informed consent;
- Female subjects are older than 18 years;
- ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
- Life expectancy≥3 months;
- Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous histology
Who cannot join
- Personnel involved in the formulation or implementation of the research plan;
- The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
Trial locations and contacts
1 site in 1 country.
Xiaoxiang Chen, MD,PhD contact
China1 site
Xiaoxiang Chen
Nanjing, Jiangsu, 210009
Jing Ni, MD, +8613813833586, nijingwulin@126.com
Xiaoxiang Chen
About this study
Official title: Variance of HRD From Primary to Recurrent in High-grade Serous Ovarian Cancer
Homologous recombination deficiency (HRD) is an important biomarker of poly (ADP-ribose) polymerase inhibitor (PARPi) in patients with high-grade serous ovarian cancer (HGSOC). The stability of HRD in the recurrent HGSOC and its primary pair remains unknown.
Read the detailed description
This study intends to perform HRD testing of ovarian cancer in the recurrent HGSOC and its primary pair, furtherly correlate HRD status and clinical characteristics in the recurited population.
- Conditions
- Ovarian Cancer, HRD, Platinum-sensitive Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer
The LOH score is a scale describing the genomic loss of heterozygosity status in the primary or recurrent tumor of an ovarian cancer patient. The score is determined by analyzing more than 3500 SNPs spaced at 1Mb intervals across the genome on the FoundationOne CDx test and extrapolating an LOH profile, excluding arm and chromosome-wide LOH segments. The score is summarized as the percentage of the genome with LOH regions.
Measured: Through study completion, an average of 1 year]
Homologous recombination deficiency (HRD) status
The HRD status for primary or recurrent tumor in a patient is considered according to the LOH score and genomic mutation status of BRCA1 and BRCA2 genes in the sample. A sample with LOH≥16%，and/or with genomic mutation in BRCA1 or BRCA2 gene, is defined as HRD positive. Otherwise, a sample with LOH<16% and wild type BRCA1/BRCA2 genes is defined as HRD negative.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Progression-free survival
Progression-free survival in recruited patients
Measured: From the beginning of the patient's onset, an average of 1 year
Overall survival
Overall survival in recruited patients
Measured: From the beginning of the patient's onset, 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 posted6 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoxiang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoxiang Chen, Jiangsu Cancer Institute & Hospital
- Investigators
- Xiaoxiang Chen Chen, MD,PhD, Study chair, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069818
- Sponsor's protocol ID
- JiangsuCIH011
- Acronym
- HOPEII
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variance of HRD From Primary to Recurrent in High-grade Serous Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05069818
- Acronym / sponsor ID
- HOPEII / JiangsuCIH011
- Conditions
- Ovarian Cancer, HRD, Platinum-sensitive Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xiaoxiang ChenUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Oct 2021 (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.
Homologous recombination deficiency (HRD) is an important biomarker of poly (ADP-ribose) polymerase inhibitor (PARPi) in patients with high-grade serous ovarian cancer (HGSOC). The stability of HRD in the recurrent HGSOC and its primary pair remains unknown.
Detailed description
This study intends to perform HRD testing of ovarian cancer in the recurrent HGSOC and its primary pair, furtherly correlate HRD status and clinical characteristics in the recurited population.
Study design
- Observational model
- Cohort
- 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
- Platinum-sensitive relapsed high-grade serous ovarian cancer patients undergoing secondary cytoreductive surgery
Key inclusion criteria (5 listed)
- Subjects join the study voluntarily and sign informed consent;
- Female subjects are older than 18 years;
- ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
- Life expectancy≥3 months;
- Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous histology
Key exclusion criteria (2 listed)
- Personnel involved in the formulation or implementation of the research plan;
- The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
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
Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer
Time frame: Through study completion, an average of 1 year]
The LOH score is a scale describing the genomic loss of heterozygosity status in the primary or recurrent tumor of an ovarian cancer patient. The score is determined by analyzing more than 3500 SNPs spaced at 1Mb intervals across the genome on the FoundationOne CDx test and extrapolating an LOH profile, excluding arm and chromosome-wide LOH segments. The score is summarized as the percentage of the genome with LOH regions.
Homologous recombination deficiency (HRD) status
Time frame: Through study completion, an average of 1 year
The HRD status for primary or recurrent tumor in a patient is considered according to the LOH score and genomic mutation status of BRCA1 and BRCA2 genes in the sample. A sample with LOH≥16%，and/or with genomic mutation in BRCA1 or BRCA2 gene, is defined as HRD positive. Otherwise, a sample with LOH<16% and wild type BRCA1/BRCA2 genes is defined as HRD negative.
2 secondary outcomes
Progression-free survival
Time frame: From the beginning of the patient's onset, an average of 1 year
Overall survival
Time frame: From the beginning of the patient's onset, an average of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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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.
Xiaoxiang Chen, MD,PhD contact
Xiaoxiang Chen Chen, MD,PhD study chair
Jiangsu Cancer Institute & 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 Ovarian Cancer and HRD, run by Xiaoxiang Chen 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 5 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 6 Oct 2021. 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 Jing Ni, MD (+86 13327833586, nijingwulin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer (time frame: Through study completion, an average of 1 year]). The study lists 2 primary outcomes in all. 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 6 Oct 2021.