Variance of HRD From Paired Ovarian Cancer (HOPEII)

September 25, 2021 updated by: Xiaoxiang Chen

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

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
        • Contact:
        • Contact:
          • Xiaoxiang Chen

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

Platinum-sensitive relapsed high-grade serous ovarian cancer patients undergoing secondary cytoreductive surgery

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 histology

Exclusion Criteria:

  1. Personnel involved in the formulation or implementation of the research plan;
  2. 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;

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From the beginning of the patient's onset, an average of 1 year
Progression-free survival in recruited patients
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
Overall survival in recruited patients
From the beginning of the patient's onset, an average of 3 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 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)

October 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 25, 2021

First Submitted That Met QC Criteria

September 25, 2021

First Posted (ACTUAL)

October 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 25, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JiangsuCIH011

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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