NCT06083779

Brief Summary

The purpose of this study is to enable non-invasive early detection of endometrial 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 endometrial cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five different feature types, including Fragment Size Distribution, nucleosome features, SBS Signatures, BreakPoint Motif , and Copy Number Variation 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
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

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

August 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

October 16, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

October 9, 2023

Last Update Submit

October 9, 2023

Conditions

Endometrial Cancer

Keywords

Endometrial CancerEarly StagePlasma Cell-free DNAFragmentomic assay

Outcome Measures

Primary Outcomes (1)

  • Area under curve of the model for detecting endometrial cancer

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

    1 year

Study Arms (2)

Patients with endometrial cancer

the 108 patients with early to mid-stage endometrial cancer, more than 50% were in FIGO stages I/II.

Genetic: low-depth whole-genome sequencing technology

healthy people

108 healthy people

Genetic: low-depth whole-genome sequencing technology

Interventions

low-depth whole-genome sequencing technologyGENETIC

the characteristics of five cfDNA fragments based on low-depth whole-genome sequencing technology (WGS)

Patients with endometrial cancerhealthy people

Eligibility Criteria

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

Approximately 108 early to mid-stage endometrial cancer patients and 108 non-cancer controls

You may qualify if:

  • Age minimum 18 years
  • Patients diagnosed with early to mid-stage endometrial cancer (more than 50% are in FIGO stages I/II) through histological and/or cytological examination.
  • Ability to understand and the willingness to sign a written informed consent document
  • Participants can obtain comprehensive clinical and pathological information.
  • 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-endometrial 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

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bingzhong Zhang, MD

    The 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

October 9, 2023

First Posted

October 16, 2023

Study Start

August 1, 2023

Primary Completion

January 31, 2024

Study Completion

April 30, 2024

Last Updated

October 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)