NCT05310357

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 26, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2024

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 26, 2022

Last Update Submit

March 26, 2022

Conditions

Epithelial Ovarian CancerHigh-grade Serous Ovarian CarcinomaChromosomal InstabilitySomatic Copy Number DistortionSurvival OutcomesMinimal Residual LesionsProgression-free SurvivalOverall Survival

Outcome Measures

Primary Outcomes (1)

  • Incidence of chromosomal instability (CIN)

    Incidence of chromosomal instability tested in peripheral cell-free DNA

    One year

Secondary Outcomes (2)

  • Progression-free survival

    One year

  • Overall survival

    One year

Interventions

Testing for chromosomal instability (CIN)DIAGNOSTIC_TEST

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients confirmed of primary ovarian high grade serous carcinoma.

You may qualify if:

  • 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

You may not qualify if:

  • Declining to anticipate the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

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.

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialChromosomal Instability

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersChromosome AberrationsPathologic ProcessesPathological Conditions, Signs and SymptomsGenomic Instability

Study Officials

  • Lei Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

86-139-1198-8831lileigh@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 4, 2022

Study Start

March 26, 2022

Primary Completion

March 26, 2023

Study Completion

March 26, 2024

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations

CN(1)