Clinical trial NCT05647109: Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer
Official title: Department of Obstetrics & Gynecology ，Peking University People's Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Carcinoma Stage I
Atypical Endometrial Hyperplasia
Keywords: Progesterone
Patient-derived tumor-like cell clusters
Endometrial Carcinoma
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
name: Beihang University
First posted: 2022-12-12
Enrollment: 244
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: sensitivity
timeFrame: 7 months
measure: accuracy
timeFrame: 7 months
Secondary outcomes:
measure: false-negative rate
timeFrame: 7 months
measure: false-positive rate
timeFrame: 7 months
Other outcomes:
Locations:
city: Pekín
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: