Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients

NCT05044091 | Unknown

• 1 other identifier: JiangsuCIH010
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Homologous recombination deficiency (HRD) is an important molecular biomarker for Poly (ADP-ribose) polymerase inhibitors (PARPi) which is a significant progress in the treatment of ovarian cancer. However, the proportion of HRD positive in real world and relationship of HRD status with PARPi in Chinese ovarian cancer patients remains unknown.

Conditions

Ovarian Cancer; HRD; PARP Inhibitor

Keywords

Ovarian caner, HRD, PARP inhibitor

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.

  Through study completion, an average of 1 year

• Progression Free Survival (PFS)

  PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.

  Through study completion, an average of 1 year

Study Arms (1)

ovarian/fallopian tube/primary peritoneal cancer patients

ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks

Drug: PARP inhibitor

Interventions

PARP inhibitor DRUG

Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions

Also known as: Lynparza, Zejula

ovarian/fallopian tube/primary peritoneal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ovarian/fallopian tube/primary peritoneal cancer patients treated with PARP inhibitor in the real word.

You may qualify if:

• Subjects join the study voluntarily and sign informed consent;
• Female subjects are older than 18 years;
• ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
• Life expectancy≥3 months;
• 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;
• Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

You may not qualify if:

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

Sponsors & Collaborators

• Xiaoxiang Chen: lead

Study Sites (1)

Xiaoxiang Chen, MD,PhD

Nanjing, Jiangsu, 210009, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The formalin fixation and paraffin embedding (FFPE ) samples from the cytoreductive surgery will be obtained after patients' informed consent.

MeSH Terms

Conditions

Ovarian Neoplasms; Kenny-Caffey syndrome, Type 1

Interventions

Poly(ADP-ribose) Polymerase Inhibitors; olaparib; niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Xiaoxiang Chen, MD,PhD

  Jiangsu Cancer Institute & Hospital

  STUDY CHAIR

Central Study Contacts

Jing Ni, MD

CONTACT

+86 13327833586; nijingwulin@126.com

Xiaoxiang Chen, MD,PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Academic secretary of gynecological oncology Committee of Jiangsu anti cancer association

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 14, 2021
• Study Start: September 15, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)