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Clinical Trials/NCT05310357
NCT05310357
Unknown
Not Applicable

The Role of Chromosomal Instability in Monitoring the Course of Ovarian High-grade Serous Carcinoma

Lei Li1 site in 1 country300 target enrollmentMarch 26, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epithelial Ovarian Cancer
Sponsor
Lei Li
Enrollment
300
Locations
1
Primary Endpoint
Incidence of chromosomal instability (CIN)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2022
End Date
March 26, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Lei Li
Responsible Party
Sponsor Investigator
Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of chromosomal instability (CIN)

Time Frame: One year

Incidence of chromosomal instability tested in peripheral cell-free DNA

Secondary Outcomes

  • Progression-free survival(One year)
  • Overall survival(One year)

Study Sites (1)

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