Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Observational
Started
2024-08-20
Last updated
2024-10-02
Condition(s) studied
Exploring the Correlation of HRD Score Pairs with the Prognosis of Chinese Ovarian Cancer Patients and the Outcome of Maintenance Therapy with PARPi
Investigational drug(s) / intervention(s)
Non-interventional
Non-interventional: Non-interventional
Study summary
This study plans to retrospectively include 470 initial surgical specimens from 470 patients with epithelial ovarian, fallopian tube or primary peritoneal cancers who were treated with PARPi maintenance therapy in the hospital from 2018.01 to 2024.01. All patients included would be scored by the proprietary HRD ADx-GSS® algorithm with the detecting results of the three genomic statuses including heterozygous omission (LOH), telomere allelic imbalance (TAI), and large-segment translocation (LST). Finally, the correlation between the HRD scores and the prognosis of Chinese ovarian cancer patients and the efficacy of using PARPi as maintenance treatment would be explored.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer initially diagnosed after January 2015 or platinum-sensitive recurrent patients diagnosed with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers, and are treated with PARPi maintenance therapy by January 2024 after chemotherapy or Platinum-sensitive recurrent patients diagnosed with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers, and are treated with PARPi maintenance therapy by January 2024 after chemotherapy;
2. Age ≥ 18 years, female;
3. Stable CA125 level, ECOG: 0-2 points, and appropriate cardiac, liver and renal function before using PARPi.
Exclusion Criteria:
1. other malignancies combined within 5 years;
2. poor underlying condition, one of the following: ECOG PS score \>2, KPS score \<60, cardiac insufficiency (Class III-IV), hepatic insufficiency (Child-Pugh Class C), renal insufficiency (Stage 4-5);
3. patients whose sample residuals and quality do not support the need for testing;
4. conditions that, in the judgement of the investigator, may affect the conduct of the clinical study and the determination of the study results.
Primary outcome measure(s)
HRD score — 2 years Homologous recombination deficiency score
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen memorial hospital
Guangzhou
Guangdong
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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