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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05069818
Other study ID # JiangsuCIH011
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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