The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer (ROMP)

Xiaoxiang Chen

Status: Unknown

Conditions: PARP Inhibitor; Clinical Marker; Ovarian Cancer

Treatments: Drug: PARP inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT04582552

JiangsuCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

Ovarian cancer patients treated with PARP inhibitors

Description:

PARP inhibitors therapy until disease progression

Treatment:

Drug: PARP inhibitors