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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05310357
Other study ID # EOC-CIN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 26, 2022
Est. completion date March 26, 2024

Study information

Verified date March 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date March 26, 2024
Est. primary completion date March 26, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Diagnostic Test:
Testing 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.

Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of chromosomal instability (CIN) Incidence of chromosomal instability tested in peripheral cell-free DNA One year
Secondary Progression-free survival Progression-free survival in patients accepting CIN testing One year
Secondary Overall survival Overall survival in patients accepting CIN testing One year
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