NCT06341855

Brief Summary

Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 25, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

February 18, 2024

Last Update Submit

March 25, 2024

Conditions

Endometrial Cancer

Keywords

MRDEndometrial CancerctDNA

Outcome Measures

Primary Outcomes (2)

  • monitoring recurrence and evaluating prognosis

    The correlation between ctDNA-MRD status and DFS and 2-year DFS rate before, after, during and after adjuvant therapy.

    2 years

  • Treatment benefit

    To evaluate whether intensive therapy for ctDNA-MRD-positive patients with high-risk endometrial carcinoma after adjuvant therapy can significantly improve the survival benefits of patients.

    2 years

Study Arms (2)

ctDNA positive

OTHER

If the ctDNA test result is positive, the subjects will be stratified to the treatment group or follow-up group at 1:1.

Diagnostic Test: MRD-ctDNA

ctDNA negative

OTHER

If the ctDNA test result is negative, the subjects will belong to follow-up group

Diagnostic Test: MRD-ctDNA

Interventions

MRD-ctDNADIAGNOSTIC_TEST

ctDNA-MRD is a powerful biomarker, and ctDNA-MRD is a reliable predictive biomarker in EC.

ctDNA negativectDNA positive

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGynaecological cancers
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) endometrial carcinoma with high risk of recurrence after radical surgery: stage I G3 endometrioid carcinoma, serous carcinoma, clear cell carcinoma, carcinosarcoma, dedifferentiated / undifferentiated carcinoma, II-IV stage endometrial carcinoma, operable recurrent endometrial carcinoma.
  • (2) the physical status (PS) score of the eastern tumor tissue cooperation group (ECOG) was 0 or 1.
  • (3) the treatment process should cooperate with the provision of clinicopathological and imaging data needed for the research process.
  • (4) cooperate with the follow-up and collect the blood of the clinical curative effect evaluation node, and agree to use the test data for follow-up research and product development.
  • (5) after operation, imaging examination showed no evidence of local disease or distant metastasis.

You may not qualify if:

  • (1) histological diagnosis of endometrial stromal sarcoma.
  • (2) there are contraindications of radiotherapy and chemotherapy.
  • (3) any other patients who may have poor compliance with the procedures and requirements of the study have been judged by the researchers.
  • (4) designated evaluation methods such as imaging can not be accepted or provided.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 1st hospital of Jilin University

Changchun, Jilin, China

RECRUITING

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2024

First Posted

April 2, 2024

Study Start

January 25, 2024

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)