Clinical trial NCT04582552: The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer
Official title: A Real-world Study of Clinical Markers for PARP Inhibitors in Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Clinical Marker
PARP Inhibitor
Keywords: Ovarian caner, PARP inhibitor, Clinical marker
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ovarian cancer patients treated with PARP inhibitor in the real word.

Brief summary: Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.

Detailed description: This study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of EOC patients and the efficacy of PARPi based on our existing research foundation and stratified analyse these correlations by BRCA and HRD status.

Eligibility criteria: 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 or endometrioid histology;
6. Patients should test for BRCA gene and will perform test for HRD status if who harbor BRCAwt in the same laboratory designated by the researcher;
7. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

Exclusion Criteria:

1. Personnel involved in the formulation or implementation of the research plan;
2. Patient participated in other clinical trails using other experimental drugs at the same time as the study;
3. 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;
4. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
5. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Through study completion, an average of 1 year
measure: Progression Free Survival (PFS)
timeFrame: Through study completion, an average of 1 year
measure: Duration of Response (DOR)
timeFrame: Through study completion, an average of 1 year
measure: Disease Control Rate (DCR)
timeFrame: Through study completion, an average of 1 year
measure: Adverse events (AEs)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Xiaoxiang Chen, MD,PhD
state: Jiangsu
Study officials:
affiliation: Jiangsu Cancer Institute & Hospital
name: Xiaoxiang Chen, MD,PhD
role: STUDY_CHAIR
affiliation: Jiangsu Cancer Institute & Hospital
name: Jing Ni, MD
role: PRINCIPAL_INVESTIGATOR
References: