Ovarian CancerROMPNCT04582552
The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer
An observational study of Ovarian Cancer and Clinical Marker, run by Xiaoxiang Chen at 1 site in China.
Trial summary
Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Clinical Marker, PARP Inhibitor
- What is being tested?
- PARP inhibitors
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2020to Nov 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 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 should test for BRCA gene and will perform test for HRD status if who harbor BRCAwt in the same laboratory designated by the researcher;
- 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.
China1 site, 1 recruiting
- Recruiting
Xiaoxiang Chen, MD,PhD
Nanjing, Jiangsu, 210009
Jing Ni, MD, +86 13327833586, nijingwulin@126.com
About this study
Official title: A Real-world Study of Clinical Markers for PARP Inhibitors in Epithelial Ovarian Cancer
Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.
Read the detailed description
This study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of EOC patients and the efficacy of PARPi based on our existing research foundation and stratified analyse these correlations by BRCA and HRD status.
- Conditions
- Ovarian Cancer, Clinical Marker, PARP Inhibitor
- Being tested
- PARP inhibitors
- Keywords
- Ovarian caner, PARP inhibitor, Clinical marker
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARP inhibitorsDrug
Also called Lynparza, Zejula
Ovarian cancer patients with PARP inhibitors according to the NCCN guideline and their instructions.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer patients treated with PARP inhibitors | PARP inhibitors therapy until disease progression Receives: Drug: PARP inhibitors |
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
Duration of Response (DOR)
DOR is defined as the time from the first date of response until the date of first documented progression.
Measured: Through study completion, an average of 1 year
Disease Control Rate (DCR)
DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.
Measured: Through study completion, an average of 1 year
Adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 to further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants.
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 posted9 Oct 2020
- Study start15 Dec 2020
- Primary completionMay 2022 (estimated)
- Study completionNov 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 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 & HospitalJing Ni, MD, Principal investigator, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582552
- Sponsor's protocol ID
- JiangsuCH
- Acronym
- ROMP
- Status last verified
- Jan 2021
- First submitted
- 5 Oct 2020
- Last updated
- 20 Jan 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Clinical Markers for PARP Inhibitors in Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04582552
- Acronym / sponsor ID
- ROMP / JiangsuCH
- Conditions
- Ovarian Cancer, Clinical Marker, PARP Inhibitor
- Keywords
- Ovarian caner, PARP inhibitor, Clinical marker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiaoxiang ChenUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 9 Oct 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.
Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.
Detailed description
This study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of EOC patients and the efficacy of PARPi based on our existing research foundation and stratified analyse these correlations by BRCA and HRD status.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients treated with PARP inhibitors | – | Drug: PARP inhibitorsPARP inhibitors therapy until disease progression |
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 treated with PARP inhibitor in the real word.
Key inclusion criteria (7 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 inhibitorsAlso: Lynparza, ZejulaOvarian cancer patients with PARP inhibitors according to the NCCN guideline and their instructions. | Drug | Ovarian cancer patients treated with PARP inhibitors |
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.
Duration of Response (DOR)
Time frame: Through study completion, an average of 1 year
DOR is defined as the time from the first date of response until the date of first documented progression.
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 1 year
DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.
Adverse events (AEs)
Time frame: Through study completion, an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 to further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No. Contact Prof. Chen and Dr. Ni for primary data.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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 study chair
Jiangsu Cancer Institute & Hospital
Jing Ni, MD principal investigator
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 Clinical Marker, 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 7 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 20 Jan 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 5 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 20 Jan 2021.