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Chromosomal Instability in Ovarian Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05310357
Enrollment
300
Registered
2022-04-04
Start date
2022-03-26
Completion date
2024-03-26
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTTesting for chromosomal instability (CIN)

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.

Sponsors

Lei Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of chromosomal instability (CIN)One yearIncidence of chromosomal instability tested in peripheral cell-free DNA

Secondary

MeasureTime frameDescription
Progression-free survivalOne yearProgression-free survival in patients accepting CIN testing
Overall survivalOne yearOverall survival in patients accepting CIN testing

Countries

China

Contacts

Primary ContactLei Li, M.D.
lileigh@163.com86-139-1198-8831

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026