Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• (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.

Locations
Other Locations
China
the 1st hospital of Jilin University
RECRUITING
Changchun
Time Frame
Start Date: 2024-01-25
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 100
Treatments
Other: ctDNA positive
If the ctDNA test result is positive, the subjects will be stratified to the treatment group or follow-up group at 1:1.
Other: ctDNA negative
If the ctDNA test result is negative, the subjects will belong to follow-up group
Related Therapeutic Areas
Sponsors
Leads: The First Hospital of Jilin University
Collaborators: Geneplus-Beijing Co. Ltd.

This content was sourced from clinicaltrials.gov