Variance of HRD From Paired Ovarian Cancer

Ovarian Cancer Clinical Trial

— HOPEII  

Official title:

Variance of HRD From Primary to Recurrent in High-grade Serous Ovarian Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05069818
• Other study ID #: JiangsuCIH011
• Status: Not yet recruiting
• Start date: October 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Jing Ni, MD
• Phone: +86 13327833586
• Email: nijingwulin[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• HRD
• Ovarian Cancer
• Ovarian Neoplasms
• Platinum-sensitive Ovarian Cancer

Locations

Country	Name	City	State
China	Xiaoxiang Chen	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoxiang Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer	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]
Primary	Homologous recombination deficiency (HRD) status	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	Progression-free survival	Progression-free survival in recruited patients	From the beginning of the patient's onset, an average of 1 year
Secondary	Overall survival	Overall survival in recruited patients	From the beginning of the patient's onset, an average of 3 year