NCT05693987

Brief Summary

The purpose of this study is to enable non-invasive early detection of ovarian cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage ovarian cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five diferent feature types, including Fragment Size Coverage (FSC), Fragment Size Distribution (FSD), EnD Motif (EDM), BreakPoint Motif (BPM), and Copy Number Variation (CNV) will be assessed to generate this model.

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
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 12, 2023

Last Update Submit

January 12, 2023

Conditions

Ovarian Cancer

Keywords

Ovarian CancerPlasma Cell-free DNAFragmentomic assayEarly detection

Outcome Measures

Primary Outcomes (1)

  • Area under curve of the model for detecting ovarian cancer

    The area under curve of the model for the ultrasensitive early detection of ovarian cancer would be evaluate

    1 year

Secondary Outcomes (2)

  • Sensitivity of the early detection model

    1 year

  • Specificity of the early detection model

    1 year

Study Arms (4)

stage I-II ovarian cancer

54 patients with stage I-II ovarian cancer

stage III-IV ovarian cancer

54 patients with stage III-IV ovarian cancer

benign ovarian cancer

40 patients with benign ovarian cancer

healthy people

100 healthy people

Eligibility Criteria

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

54 patients with stage I-II ovarian cancer, 54 patients with stage III-IV ovarian cancer, 40 patients with benign ovarian cancer and 100 healthy people were enrolled.

You may qualify if:

  • Age minimum 18 years
  • Patients with I-IV ovarian cancer or benign tumor confirmed by pathological examination.
  • Ability to understand and the willingness to sign a written informed consent document
  • Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening

You may not qualify if:

  • Participants must not be pregnant or breastfeeding
  • Participants must not have prior cancer histories or a second non-ovarian malignancy
  • Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
  • Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
  • Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
  • Participants with clinically important abnormalities or conditions unsuitable for blood collection
  • Any other disease or clinical condition of participants that the researcher believes may affect the compliance of the protocol, or affect the patient's signing of the informed consent form (ICF), which is not suitable to participate in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Cell-free DNA

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Bingzhong Zhang, MD

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingzhong Zhang, MD

CONTACT

1392506303013925063030@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

November 1, 2022

Primary Completion

February 28, 2023

Study Completion

April 30, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

CN(1)