Chromosomal Instability in Ovarian Cancer

Sponsor
Lei Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT05310357
Collaborator
(none)
300
1
24
12.5

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Role of Chromosomal Instability in Monitoring the Course of Ovarian High-grade Serous Carcinoma
Actual Study Start Date :
Mar 26, 2022
Anticipated Primary Completion Date :
Mar 26, 2023
Anticipated Study Completion Date :
Mar 26, 2024

Outcome Measures

Primary Outcome Measures

  1. Incidence of chromosomal instability (CIN) [One year]

    Incidence of chromosomal instability tested in peripheral cell-free DNA

Secondary Outcome Measures

  1. Progression-free survival [One year]

    Progression-free survival in patients accepting CIN testing

  2. Overall survival [One year]

    Overall survival in patients accepting CIN testing

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lei Li Beijing Beijing China 100730

Sponsors and Collaborators

  • Lei Li

Investigators

  • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05310357
Other Study ID Numbers:
  • EOC-CIN
First Posted:
Apr 4, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022