Chromosomal Instability in Ovarian Cancer

• Conditions: Survival Outcomes; Epithelial Ovarian Cancer; High-grade Serous Ovarian Carcinoma; Chromosomal Instability; Somatic Copy Number Distortion; Overall Survival; Minimal Residual Lesions; Progression-free Survival

• Registration Number: NCT05310357
• Lead Sponsor: Lei Li

Brief Summary

Chromosomal instability (CIN) refers to the ongoing genomic change, which involves the amplification or deletion of chromosome copy number or structure. The changes rang from point mutation to small-scale genomic change and even the change of whole chromosome number. It has been reported that the characteristics of genomic rearrangement can be used as a marker of clinical outcome of high-grade serous ovarian cancer, and specific genomic rearrangement are related to the poor prognosis. In noninvasive gene detection with low coverage, patients diagnosed with ovarian cancer have deteriorating progression-free and overall survivals regardless of the tumor stage when somatic copy number distortion (sCNA) exceeds the threshold in plasma. The detection rate of sCNA increased along with the tumor stage. We enrolled those as our target patients, who are diagnosed with high-grade serous ovarian cancer and willing to take part in. The CIN in peripheral cell-free DNA was observed before initial treatment, after primary debulking or staging surgeries, before recurrence and during the process of recurrence treatment. Our aim is to explore the application of CIN in peripheral tumor DNA in the detection of minimal residual lesions (MRD) after primary treatment and recurrence monitoring.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-26
• Study First Submitted: 2022-03-26
• Study First Submitted QC: 2022-03-26
• Last Update Submitted: 2022-03-26
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2023-03-26
• Study Completion: 2024-03-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Confirmed of primary ovarian high grade serous carcinoma (HGSC)
• Aged 18 years or older
• Acceptance of surgical treatment for HGSC
• With detailed follow-up outcomes

Exclusion Criteria

• Not meeting all of the inclusion criteria
• Declining to anticipate the trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of chromosomal instability (CIN)	One year	Incidence of chromosomal instability tested in peripheral cell-free DNA

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	One year	Progression-free survival in patients accepting CIN testing
Overall survival	One year	Overall survival in patients accepting CIN testing

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China