Ovarian CancerHOPEINCT05044091
Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients
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 molecular biomarker for Poly (ADP-ribose) polymerase inhibitors (PARPi) which is a significant progress in the treatment of ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, HRD, PARP Inhibitor
- What is being tested?
- PARP inhibitor
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2021to Sep 2023
- 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/fallopian tube/primary peritoneal cancer patients treated with PARP inhibitor in the real word.
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 or endometrioid histology;
- Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.
Who cannot join
- Personnel involved in the formulation or implementation of the research plan;
- Patient participated in other clinical trails using other experimental drugs at the same time as the study;
- 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;
- Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.
Trial locations and contacts
1 site in 1 country.
Xiaoxiang Chen, MD,PhD contact
China1 site
Xiaoxiang Chen, MD,PhD
Nanjing, Jiangsu, 210009
Jing Ni, MD, +86 13327833586, nijingwulin@126.com
About this study
Official title: Homologous Recombination Deficiency Associated With Response to Poly (ADP-ribose) Polymerase Inhibitors in Ovarian Cancer Patients: the First Real-word Evidence From China
Homologous recombination deficiency (HRD) is an important molecular biomarker for Poly (ADP-ribose) polymerase inhibitors (PARPi) which is a significant progress in the treatment of ovarian cancer. However, the proportion of HRD positive in real world and relationship of HRD status with PARPi in Chinese ovarian cancer patients remains unknown.
Read the detailed description
This study intends to perform HRD testing of ovarian cancer in real world from China and correlate HRD status and clinical characteristics with therapeutic outcomes.
- Conditions
- Ovarian Cancer, HRD, PARP Inhibitor
- Being tested
- PARP inhibitor
- Keywords
- Ovarian caner, HRD, PARP inhibitor
- Medical subject headings
- Ovarian Neoplasms, Kenny-Caffey syndrome, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARP inhibitorDrug
Also called Lynparza, Zejula
Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions
| Study group | Role | What they receive |
|---|---|---|
| ovarian/fallopian tube/primary peritoneal cancer patients | ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks Receives: Drug: PARP inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
Measured: Through study completion, an average of 1 year
Progression Free Survival (PFS)
PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start15 Sep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (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
- 100 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, MD,PhD, Study chair, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044091
- Sponsor's protocol ID
- JiangsuCIH010
- Acronym
- HOPEI
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact Prof. Chen and Dr. Ni for primary data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homologous Recombination Deficiency Associated With Response to Poly (ADP-ribose) Polymerase Inhibitors in Ovarian Cancer Patients: the First Real-word Evidence From China
- ClinicalTrials.gov ID
- NCT05044091
- Acronym / sponsor ID
- HOPEI / JiangsuCIH010
- Conditions
- Ovarian Cancer, HRD, PARP Inhibitor
- Keywords
- Ovarian caner, HRD, PARP inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiaoxiang ChenUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 14 Sep 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 molecular biomarker for Poly (ADP-ribose) polymerase inhibitors (PARPi) which is a significant progress in the treatment of ovarian cancer. However, the proportion of HRD positive in real world and relationship of HRD status with PARPi in Chinese ovarian cancer patients remains unknown.
Detailed description
This study intends to perform HRD testing of ovarian cancer in real world from China and correlate HRD status and clinical characteristics with therapeutic outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ovarian/fallopian tube/primary peritoneal cancer patients | – | Drug: PARP inhibitorovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ovarian/fallopian tube/primary peritoneal cancer patients treated with PARP inhibitor in the real word.
Key inclusion criteria (6 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 or endometrioid histology;
Key exclusion criteria (5 listed)
- Personnel involved in the formulation or implementation of the research plan;
- Patient participated in other clinical trails using other experimental drugs at the same time as the study;
- 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;
- Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.
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 |
|---|---|---|
| PARP inhibitorAlso: Lynparza, ZejulaOvarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions | Drug | ovarian/fallopian tube/primary peritoneal cancer patients |
Primary outcome
Overall Response Rate (ORR)
Time frame: Through study completion, an average of 1 year
ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
Progression Free Survival (PFS)
Time frame: Through study completion, an average of 1 year
PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No. Contact Prof. Chen and Dr. Ni for primary data.
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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, 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 6 inclusion and 5 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 14 Sep 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?
Overall Response Rate (ORR) (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 14 Sep 2021.