An observational study in Endometrial Carcinoma Stage I and Atypical Endometrial Hyperplasia, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to female participants aged 17 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Peking University People's Hospital · Observational
Among 19 studies in Endometrial Neoplasms by Peking University People's Hospital — 15 open to participants now, 15 under way, none of them phase 3. Endometrial Neoplasms · Peking University People's Hospital.
Among the 19 studies in Endometrial Neoplasms by Peking University People's Hospital, this one is the only one that started in 2021, is the only observational one, reaches primary completion later than 3 of the 14 other live ones, and was the 4th registered.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 244 is above the median of 179 across 331 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →15 of the 19 studies in Endometrial Neoplasms by Peking University People's Hospital are open now, in 1 country. Each count lists the studies.
Of the 359 Endometrial Neoplasms studies recruiting now, 269 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 27 take children under 18; 23 take healthy volunteers.
This study: 17 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2021.
Median enrollment 94 across the 18 interventional studies, 244 across the 1 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
5 of the studies in Endometrial Neoplasms by Peking University People's Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06169449Peking University People's HospitalWeight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment | 2026-12-31 |
| NCT06942377Peking University People's HospitalCalcium Channel Blocker Amlodipine for Endometrial Cancer Therapy | 2027-01-01 |
| NCT06901778Peking University People's HospitalApplication-Assisted Weight Management in Endometrial Cancer Fertility Preservation | 2027-03-31 |
| NCT07714070Peking University People's HospitalOrlistat Plus Progestin for Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia | 2027-09 |
| NCT07586826Peking University People's HospitalRomiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors | 2027-10-31 |
Among the 19 studies in Endometrial Neoplasms by Peking University People's Hospital, from their registry updates:
To construct a prediction model of progesterone sensitivity in patients with endometrial cancer treated with fertility preservation
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: No intervention
A verification set of the prediction model was established, consisting of 96 patients with endometrial cancer and atypical endometrial hyperplasia.
Other: No intervention
No intervention
sensitivity
The sensitivity of the prediction model
Time frame: 7 months
accuracy
The accuracy of the prediction model
Time frame: 7 months
false-negative rate
The false-negative rate of the prediction model
Time frame: 7 months
false-positive rate
The false-positive rate of the prediction model
Time frame: 7 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2021 (actual). Primary completion is estimated for Aug 2025, 47 months after the start.
Of 130 non-industry observational studies under Endometrial Neoplasms, half reached primary completion within 105 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 206. This study's planned 47 months is below that.
Counting every sponsor, half of 150 studies reached it within 105 months; a quarter within 32 and three quarters within 207.
How these figures are worked out, and which studies are left out of them.
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