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Trial Title:
Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer
NCT ID:
NCT05647109
Condition:
Endometrial Carcinoma Stage I
Atypical Endometrial Hyperplasia
Conditions: Official terms:
Endometrial Neoplasms
Endometrial Hyperplasia
Hyperplasia
Conditions: Keywords:
Progesterone
Patient-derived tumor-like cell clusters
Endometrial Carcinoma
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
No intervention
Arm group label:
Set of training
Arm group label:
Set of verification
Summary:
To construct a prediction model of progesterone sensitivity in patients with endometrial
cancer treated with fertility preservation
Detailed description:
After diagnosed of early endometrial carcinoma (EEC) or atypical endometrial hyperplasia
(AEH) by hysteroscopy, patients meet the study criteria will be enrolled.
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.
Criteria for eligibility:
Study pop:
This study focused on young, pre-menopausal patients with atypical endometrial
hyperplasia or endometrioid adenocarcinoma diagnosed by hysteroscopic biopsy, who had a
strong desire to preserve reproductive function.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Have a confirmed pathological diagnosis based upon hysteroscopy: atypical
endometrial hyperplasia or histologically prove well-differentiated EEC G1 without
myometrial invasion
- 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:
- Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- 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
Gender:
Female
Minimum age:
17 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Pekín
Country:
China
Status:
Recruiting
Contact:
Last name:
WANG JIANLIU, PHD/MD
Phone:
+86108832438
Email:
wangjianliu1203@163.com
Start date:
September 1, 2021
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University
Agency class:
Other
Collaborator:
Agency:
Beihang University
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05647109
