Variance of HRD From Paired Ovarian Cancer

NCT05069818 | Unknown

• 1 other identifier: JiangsuCIH011
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; HRD; Platinum-sensitive Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• 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]

• 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 Outcomes (2)

• Progression-free survival

  From the beginning of the patient's onset, an average of 1 year

• Overall survival

  From the beginning of the patient's onset, an average of 3 year

Eligibility Criteria

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

Study Population

Platinum-sensitive relapsed high-grade serous ovarian cancer patients undergoing secondary cytoreductive surgery

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 histology

You may not qualify if:

• Personnel involved in the formulation or implementation of the research plan;
• 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;

Sponsors & Collaborators

• Xiaoxiang Chen: lead

Study Sites (1)

Xiaoxiang Chen

Nanjing, Jiangsu, 210009, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Officials

• Xiaoxiang Chen 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 25, 2021
• First Posted: October 6, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

CN (1)