The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer (ROMP)

January 17, 2021 updated by: Xiaoxiang Chen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Xiaoxiang Chen, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Ovarian cancer patients treated with PARP inhibitor in the real word.

Description

Inclusion Criteria:

  1. Subjects join the study voluntarily and sign informed consent;
  2. Female subjects are older than 18 years;
  3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
  4. Life expectancy≥3 months;
  5. 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;
  6. 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;
  7. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

Exclusion Criteria:

  1. Personnel involved in the formulation or implementation of the research plan;
  2. Patient participated in other clinical trails using other experimental drugs at the same time as the study;
  3. 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;
  4. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
  5. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ovarian cancer patients treated with PARP inhibitors
PARP inhibitors therapy until disease progression
Drug: PARP inhibitors
Ovarian cancer patients with PARP inhibitors according to the NCCN guideline and their instructions.
Other Names:
  • Lynparza, Zejula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoxiang Chen

Investigators

  • Study Chair: Xiaoxiang Chen, MD,PhD, Jiangsu Cancer Institute & Hospital
  • Principal Investigator: Jing Ni, MD, Jiangsu Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JiangsuCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Contact Prof. Chen and Dr. Ni for primary data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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