Variance of HRD From Paired Ovarian Cancer

• Conditions: HRD; Platinum-sensitive Ovarian Cancer; Ovarian Cancer

• Registration Number: NCT05069818
• Lead Sponsor: Xiaoxiang Chen

Brief Summary

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.

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 Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-25
• Study First Submitted QC: 2021-09-25
• Last Update Submitted: 2021-09-25
• Study Start: 2021-10
• Study First Posted: 2021-10-06
• Last Update Posted: 2021-10-06
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer	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.
Homologous recombination deficiency (HRD) status	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	From the beginning of the patient's onset, an average of 1 year	Progression-free survival in recruited patients
Overall survival	From the beginning of the patient's onset, an average of 3 year	Overall survival in recruited patients

Trial Locations

Locations (1)

Xiaoxiang Chen; 🇨🇳 Nanjing, Jiangsu, China