Endometrial Carcinoma Stage INCT05647109
Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer
An observational study of Endometrial Carcinoma Stage I and Atypical Endometrial Hyperplasia, run by Peking University People's Hospital at 1 site in China.
Trial summary
To construct a prediction model of progesterone sensitivity in patients with endometrial cancer treated with fertility preservation Read more about this study
- Who is it for?
- Ages 17 to 45 years, women only
- Conditions the study is for
- Endometrial Carcinoma Stage I, Atypical Endometrial Hyperplasia
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Oct 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
WANG JIANLIU, PHD/MD, +86108832438, wangjianliu1203@163.com
About this study
Official title: Department of Obstetrics & Gynecology ，Peking University People's Hospital
To construct a prediction model of progesterone sensitivity in patients with endometrial cancer treated with fertility preservation
Read the 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.
- Being tested
- No intervention
- Keywords
- Progesterone, Patient-derived tumor-like cell clusters, Endometrial Carcinoma
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
The sensitivity of the prediction model
Measured: 7 months
accuracy
The accuracy of the prediction model
Measured: 7 months
Secondary outcomes (2)
false-negative rate
The false-negative rate of the prediction model
Measured: 7 months
false-positive rate
The false-positive rate of the prediction model
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Sep 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Carcinoma Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 244 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Beihang University
- Responsible party
- Principal investigator, Wang Jianliu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647109
- Sponsor's protocol ID
- 2022PHB409
- Status last verified
- Apr 2025
- First submitted
- 2 Dec 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Obstetrics & Gynecology ，Peking University People's Hospital
- ClinicalTrials.gov ID
- NCT05647109
- Acronym / sponsor ID
- 2022PHB409
- Keywords
- Progesterone, Patient-derived tumor-like cell clusters, Endometrial Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University, Beihang University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Set of training | – | Other: No interventionA 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. |
| Set of verification | – | Other: No interventionA verification set of the prediction model was established, consisting of 96 patients with endometrial cancer and atypical endometrial hyperplasia. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Set of training, Set of verification |
Primary outcome
sensitivity
Time frame: 7 months
The sensitivity of the prediction model
accuracy
Time frame: 7 months
The accuracy of the prediction model
2 secondary outcomes
false-negative rate
Time frame: 7 months
false-positive rate
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Carcinoma Stage I and Atypical Endometrial Hyperplasia, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WANG JIANLIU, PhD/MD (8601088324383, wangjianliu1203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.