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Chromosomal Instability in Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT05310357
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Epithelial Ovarian Cancer High-grade Serous Ovarian Carcinoma Chromosomal Instability Somatic Copy Number Distortion Survival Outcomes Minimal Residual Lesions Progression-free Survival Overall Survival Diagnostic Test: Testing for chromosomal instability (CIN)

Study Design
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Study Type : Observational
Estimated 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 : March 26, 2022
Estimated Primary Completion Date : March 26, 2023
Estimated Study Completion Date : March 26, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Incidence of chromosomal instability (CIN) [ Time Frame: One year ]
    Incidence of chromosomal instability tested in peripheral cell-free DNA


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: One year ]
    Progression-free survival in patients accepting CIN testing

  2. Overall survival [ Time Frame: One year ]
    Overall survival in patients accepting CIN testing


Biospecimen Retention:   Samples With DNA
The chromosomal instability 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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Patients confirmed of primary ovarian high grade serous carcinoma.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05310357


Contacts
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Contact: Lei Li, M.D. 86-139-1198-8831 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
More Information
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT05310357    
Other Study ID Numbers: EOC-CIN
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Genomic Instability
Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Chromosomal Instability
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
 Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pathologic Processes
Chromosome Aberrations