Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer
NCT ID: NCT05647109
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
244 participants
OBSERVATIONAL
2021-09-01
2025-10-31
Brief Summary
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Detailed Description
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Patients will receive MPA (Medroxyprogesterone acetate) 250-500mg or MA (megestrol acetate) 160-320mg by mouth daily. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. Hysteroscopy will continue until pathology confirms complete response. Complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to hyperplasia with or without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of higher pathological progression, or myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR or SD. Patients with PD will be recommended for hysterectomy.
During each hysteroscopy, the intraoperative residual tissues were sent to the laboratory of College of Future Science and Technology of Peking University for culture as Patient-derived tumor-like cell clusters (PTC), and the content of lipids (lipid droplet size and cholesterol content) was measured by stimulated Raman scattering imaging and recorded. After collecting the data of 148 cases, the prediction model was constructed. Then the model is validated in the validation set composed of 96 new cases. In order to determine the accuracy and sensitivity of the model.
If a patient has achieved a pathological complete response and a high lipid content is detected in the tissue by stimulated Raman scattering imaging, we will follow up for subsequent recurrence.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Set of training
A total of 148 patients with endometrial cancer and atypical endometrial hyperplasia were included in the training set of the prediction model. They were divided into progesterone sensitive group and progesterone insensitive group.
No intervention
No intervention
Set of verification
A verification set of the prediction model was established, consisting of 96 patients with endometrial cancer and atypical endometrial hyperplasia.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
* Have a desire for remaining reproductive function or uterus
* Good compliance with adjunctive treatment and follow-up
Exclusion Criteria
* Pregnancy or potential pregnancy
* Confirmed diagnosis of any cancer in reproductive system
* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
* Hypersensitivity or contradiction for using MPA or MA
* With other factors of reproductive dysfunction;
* Strong request for uterine removal or other conservative treatment
17 Years
45 Years
FEMALE
No
Sponsors
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Peking University
OTHER
Beihang University
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Wang Jianliu
Professor, Doctoral supervisor, Chief physician, Vice President
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022PHB409
Identifier Type: -
Identifier Source: org_study_id
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