Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients (HOPEI)

September 4, 2021 updated by: Xiaoxiang Chen

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

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
        • 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/fallopian tube/primary peritoneal 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 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: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ovarian/fallopian tube/primary peritoneal cancer patients
ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks
Drug: PARP inhibitor
Ovarian/fallopian tube/primary peritoneal 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
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

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

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 (Anticipated)

September 15, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

September 4, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 4, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JiangsuCIH010

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

product manufactured in and exported from the U.S.

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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