Endometrial CancerNCT07892755
Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
An observational study of Endometrial Cancer and Atypical Endometrial Hyperplasia, run by Guizhou Provincial People's Hospital at 1 site in China.
Trial summary
Endometrial cancer is one of the most common gynecological malignancies, and its incidence is rising. Currently, there is a lack of highly effective and non-invasive screening methods. Liquid biopsy, which analyzes cell-free DNA (cfDNA) in the blood, has emerged as a promising approach for early cancer detection. Read more about this study
- Who is it for?
- Ages Up to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer, Atypical Endometrial Hyperplasia
- Type of treatment
- Injection or infusion
- How many people
- 512 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to Dec 2027
- 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 Up to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: he study includes three cohorts: 216 patients with stage I-IV endometrial cancer, 80 patients with atypical endometrial hyperplasia, and 216 age-matched healthy female controls. All participants are recruited from regional Chinese populations.
Who may be able to join
- Female, aged > 18 years.
- Participants fully understand the study requirements and sign the written informed consent.
- Cohort A (Endometrial Cancer): Patients with histologically and/or cytologically confirmed stage I-IV endometrial cancer; comprehensive clinical and pathological information is available.
- Cohort B (Atypical Hyperplasia): Patients diagnosed with atypical endometrial hyperplasia; comprehensive clinical and pathological information is available.
- Cohort C (Healthy Control): Healthy female subjects with no tumors or suspicious nodules confirmed by systematic examination.
Who cannot join
- Pregnant women.
- Current diagnosis of tumors other than endometrial cancer or a history of previous tumors.
- Received any form of tumor treatment prior to blood draw, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.
- Current febrile illness, or acute/inflammatory disease requiring internal medical treatment within 14 days prior to blood draw.
- Organ transplant recipients or previous recipients of allogeneic bone marrow or stem cell transplants.
- Poor health status or unsuitable for blood draw.
- Any other clinically significant disease or condition that, in the investigator's opinion, may affect protocol compliance, affect the subject's ability to sign informed consent, or make the subject unsuitable for this clinical study.
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
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Yong Li, MD, +8613628566285, liyong7229771@163.com
Li, liyong7229771@163.com
About this study
Endometrial cancer is one of the most common gynecological malignancies, and its incidence is rising. Currently, there is a lack of highly effective and non-invasive screening methods. Liquid biopsy, which analyzes cell-free DNA (cfDNA) in the blood, has emerged as a promising approach for early cancer detection. This observational study aims to develop and evaluate a non-invasive blood test to screen for early-stage endometrial cancer and to distinguish between benign and malignant endometrial lesions.
This study plans to enroll 512 female participants, divided into three groups: 216 patients with stage I-IV endometrial cancer, 80 patients with atypical endometrial hyperplasia (a precancerous condition), and 216 healthy controls. We will collect peripheral blood samples from all participants and perform low-pass whole-genome sequencing (WGS) on the extracted plasma cfDNA. By analyzing specific DNA features (such as DNA fragment patterns, end motifs, and copy number variations) and using artificial intelligence (machine learning), we will build a predictive model. This study hopes to establish a more effective, non-invasive early screening strategy to improve the clinical diagnosis of endometrial cancer in the Chinese population.
Read the detailed description
Background and Objective:
Current clinical screening methods for endometrial cancer, such as transvaginal ultrasound and endometrial biopsy, have limitations including invasiveness and subjectivity. Recent advances in plasma DNA fragmentomics have shown great potential in oncology. This study aims to systematically evaluate the accuracy and specificity of a multi-omics cfDNA model based on whole-genome sequencing (WGS) for the risk prediction of endometrial cancer, and to assess its ability to differentiate between benign and malignant endometrial lesions.
Study Design and Participants:
This is an observational, case-control study. A total of 512 female subjects will be prospectively enrolled and divided into three cohorts:
Cohort A: 216 patients with histologically confirmed stage I-IV endometrial cancer.
Cohort B: 80 patients with atypical endometrial hyperplasia.
Cohort C: 216 age-matched healthy controls with no evidence of tumors.
Sample Collection and Sequencing:
Peripheral blood samples (8-10 mL) will be collected from all participants using EDTA tubes prior to any anti-tumor treatment. Plasma will be separated within 2 hours of collection. Cell-free DNA (cfDNA) will be extracted from the plasma, and low-pass whole-genome sequencing (WGS) will be performed using the MGI high-throughput sequencing platform. Strict quality control will be applied throughout the sample processing and sequencing stages.
Bioinformatics and Modeling:
High-quality sequencing data will be analyzed to extract comprehensive multi-dimensional cfDNA features, including:
Genomic copy number variations (CNV).
cfDNA fragment size ratios (short/long).
cfDNA fragment size distribution.
cfDNA fragment end motifs.
cfDNA fragment breakpoint motifs.
Using artificial intelligence and machine learning algorithms (such as generalized linear models, deep learning, random forest, and extreme gradient boosting), a multi-omics predictive model will be constructed and validated. The ultimate goal is to establish a highly sensitive, specific, and cost-effective non-invasive early screening model for endometrial cancer in regional Chinese populations.
- Keywords
- Liquid Biopsy, Cell-Free DNA, Whole Genome Sequencing, Fragmentomics
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Endometrial Cancer | Patients with histologically and/or cytologically confirmed stage I-IV endometrial cancer. Baseline plasma samples and complete clinical and pathological information will be collected. | |
| Cohort B: Atypical Endometrial Hyperplasia | Patients with atypical endometrial hyperplasia. Baseline plasma samples and complete clinical and pathological information will be collected. | |
| Cohort C: Healthy Control | Healthy female subjects confirmed by systematic examination to have no tumors or suspicious nodules. Age-matched with Cohorts A and B. Baseline plasma samples will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (sensitivity and specificity) of the cfDNA fragmentomics model for early screening of endometrial cancer
Evaluate the accuracy and specificity of a multi-omics cfDNA-based model (incorporating fragmentomics and copy number variation features) in predicting the risk of endometrial cancer.
Measured: At baseline (time of blood collection)
Secondary outcomes (1)
Ability of the cfDNA model to differentiate between benign and malignant endometrial lesions
Evaluate the performance of the cfDNA-based model in distinguishing atypical endometrial hyperplasia (precancerous/benign) from endometrial cancer (malignant).
Measured: At baseline (time of blood collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start10 Aug 2026
- Primary completion9 Aug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc.
- Responsible party
- Sponsor
- Investigators
- Yong Li, MD, Principal investigator, Guizhou Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892755
- Sponsor's protocol ID
- 2026-241
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cristiano S, Leal A, Phallen J, Fiksel J, Adleff V, Bruhm DC, Jensen SO, Medina JE, Hruban C, White JR, Palsgrove DN, Niknafs N, Anagnostou V, Forde P, Naidoo J, Marrone K, Brahmer J, Woodward BD, Husain H, van Rooijen KL, Orntoft MW, Madsen AH, van de Velde CJH, Verheij M, Cats A, Punt CJA, Vink GR, van Grieken NCT, Koopman M, Fijneman RJA, Johansen JS, Nielsen HJ, Meijer GA, Andersen CL, Scharpf RB, Velculescu VE. Genome-wide cell-free DNA fragmentation in patients with cancer. Nature. 2019 Jun;570(7761):385-389. doi: 10.1038/s41586-019-1272-6. Epub 2019 May 29.
PubMed 31142840Liu J, Hu D, Lin Y, Chen X, Yang R, Li L, Zhan Y, Bao H, Zang L, Zhu M, Zhu F, Yan J, Zhu D, Zhang H, Xu B, Xu Q. Early detection of uterine corpus endometrial carcinoma utilizing plasma cfDNA fragmentomics. BMC Med. 2024 Jul 29;22(1):310. doi: 10.1186/s12916-024-03531-8.
PubMed 39075419Rao Q, Zhou H, Weng W, He Y, Li N, He P, Tang W, He M, Zhu X, Zhu D, Bao H, Wu X, Wang H, Lin Z, Zhang B. Early detection, clinicopathological subtyping, and prognosis prediction for endometrial cancer patients using fragmentomics liquid biopsy assay. ESMO Open. 2025 Oct;10(10):105770. doi: 10.1016/j.esmoop.2025.105770. Epub 2025 Sep 24.
PubMed 40992272
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
- ClinicalTrials.gov ID
- NCT07892755
- Acronym / sponsor ID
- 2026-241
- Keywords
- Liquid Biopsy, Cell-Free DNA, Whole Genome Sequencing, Fragmentomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Guizhou Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc.
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 9 Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Oct 2026 (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.
Endometrial cancer is one of the most common gynecological malignancies, and its incidence is rising. Currently, there is a lack of highly effective and non-invasive screening methods. Liquid biopsy, which analyzes cell-free DNA (cfDNA) in the blood, has emerged as a promising approach for early cancer detection. This observational study aims to develop and evaluate a non-invasive blood test to screen for early-stage endometrial cancer and to distinguish between benign and malignant endometrial lesions.
This study plans to enroll 512 female participants, divided into three groups: 216 patients with stage I-IV endometrial cancer, 80 patients with atypical endometrial hyperplasia (a precancerous condition), and 216 healthy controls. We will collect peripheral blood samples from all participants and perform low-pass whole-genome sequencing (WGS) on the extracted plasma cfDNA. By analyzing specific DNA features (such as DNA fragment patterns, end motifs, and copy number variations) and using artificial intelligence (machine learning), we will build a predictive model. This study hopes to establish a more effective, non-invasive early screening strategy to improve the clinical diagnosis of endometrial cancer in the Chinese population.
Detailed description
Background and Objective:
Current clinical screening methods for endometrial cancer, such as transvaginal ultrasound and endometrial biopsy, have limitations including invasiveness and subjectivity. Recent advances in plasma DNA fragmentomics have shown great potential in oncology. This study aims to systematically evaluate the accuracy and specificity of a multi-omics cfDNA model based on whole-genome sequencing (WGS) for the risk prediction of endometrial cancer, and to assess its ability to differentiate between benign and malignant endometrial lesions.
Study Design and Participants:
This is an observational, case-control study. A total of 512 female subjects will be prospectively enrolled and divided into three cohorts:
Cohort A: 216 patients with histologically confirmed stage I-IV endometrial cancer.
Cohort B: 80 patients with atypical endometrial hyperplasia.
Cohort C: 216 age-matched healthy controls with no evidence of tumors.
Sample Collection and Sequencing:
Peripheral blood samples (8-10 mL) will be collected from all participants using EDTA tubes prior to any anti-tumor treatment. Plasma will be separated within 2 hours of collection. Cell-free DNA (cfDNA) will be extracted from the plasma, and low-pass whole-genome sequencing (WGS) will be performed using the MGI high-throughput sequencing platform. Strict quality control will be applied throughout the sample processing and sequencing stages.
Bioinformatics and Modeling:
High-quality sequencing data will be analyzed to extract comprehensive multi-dimensional cfDNA features, including:
Genomic copy number variations (CNV).
cfDNA fragment size ratios (short/long).
cfDNA fragment size distribution.
cfDNA fragment end motifs.
cfDNA fragment breakpoint motifs.
Using artificial intelligence and machine learning algorithms (such as generalized linear models, deep learning, random forest, and extreme gradient boosting), a multi-omics predictive model will be constructed and validated. The ultimate goal is to establish a highly sensitive, specific, and cost-effective non-invasive early screening model for endometrial cancer in regional Chinese populations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Endometrial Cancer | – | –Patients with histologically and/or cytologically confirmed stage I-IV endometrial cancer. Baseline plasma samples and complete clinical and pathological information will be collected. |
| Cohort B: Atypical Endometrial Hyperplasia | – | –Patients with atypical endometrial hyperplasia. Baseline plasma samples and complete clinical and pathological information will be collected. |
| Cohort C: Healthy Control | – | –Healthy female subjects confirmed by systematic examination to have no tumors or suspicious nodules. Age-matched with Cohorts A and B. Baseline plasma samples will be collected. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- he study includes three cohorts: 216 patients with stage I-IV endometrial cancer, 80 patients with atypical endometrial hyperplasia, and 216 age-matched healthy female controls. All participants are recruited from regional Chinese populations.
Key inclusion criteria (5 listed)
- Female, aged > 18 years.
- Participants fully understand the study requirements and sign the written informed consent.
- Cohort A (Endometrial Cancer): Patients with histologically and/or cytologically confirmed stage I-IV endometrial cancer; comprehensive clinical and pathological information is available.
- Cohort B (Atypical Hyperplasia): Patients diagnosed with atypical endometrial hyperplasia; comprehensive clinical and pathological information is available.
- Cohort C (Healthy Control): Healthy female subjects with no tumors or suspicious nodules confirmed by systematic examination.
Key exclusion criteria (7 listed)
- Pregnant women.
- Current diagnosis of tumors other than endometrial cancer or a history of previous tumors.
- Received any form of tumor treatment prior to blood draw, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.
- Current febrile illness, or acute/inflammatory disease requiring internal medical treatment within 14 days prior to blood draw.
- Organ transplant recipients or previous recipients of allogeneic bone marrow or stem cell transplants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance (sensitivity and specificity) of the cfDNA fragmentomics model for early screening of endometrial cancer
Time frame: At baseline (time of blood collection)
Evaluate the accuracy and specificity of a multi-omics cfDNA-based model (incorporating fragmentomics and copy number variation features) in predicting the risk of endometrial cancer.
1 secondary outcome
Ability of the cfDNA model to differentiate between benign and malignant endometrial lesions
Time frame: At baseline (time of blood collection)
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 23 Oct 2026.
- Background: PubMed 31142840Cristiano S, Leal A, Phallen J, Fiksel J, Adleff V, Bruhm DC, Jensen SO, Medina JE, Hruban C, White JR, Palsgrove DN, Niknafs N, Anagnostou V, Forde P, Naidoo J, Marrone K, Brahmer J, Woodward BD, Husain H, van Rooijen KL, Orntoft MW, Madsen AH, van de Velde CJH, Verheij M, Cats A, Punt CJA, Vink GR, van Grieken NCT, Koopman M, Fijneman RJA, Johansen JS, Nielsen HJ, Meijer GA, Andersen CL, Scharpf RB, Velculescu VE. Genome-wide cell-free DNA fragmentation in patients with cancer. Nature. 2019 Jun;570(7761):385-389. doi: 10.1038/s41586-019-1272-6. Epub 2019 May 29.
- Background: PubMed 39075419Liu J, Hu D, Lin Y, Chen X, Yang R, Li L, Zhan Y, Bao H, Zang L, Zhu M, Zhu F, Yan J, Zhu D, Zhang H, Xu B, Xu Q. Early detection of uterine corpus endometrial carcinoma utilizing plasma cfDNA fragmentomics. BMC Med. 2024 Jul 29;22(1):310. doi: 10.1186/s12916-024-03531-8.
- Background: PubMed 40992272Rao Q, Zhou H, Weng W, He Y, Li N, He P, Tang W, He M, Zhu X, Zhu D, Bao H, Wu X, Wang H, Lin Z, Zhang B. Early detection, clinicopathological subtyping, and prognosis prediction for endometrial cancer patients using fragmentomics liquid biopsy assay. ESMO Open. 2025 Oct;10(10):105770. doi: 10.1016/j.esmoop.2025.105770. Epub 2025 Sep 24.
- 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.
Yong Li, MD principal investigator
Guizhou Provincial People's Hospital
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 Cancer and Atypical Endometrial Hyperplasia, run by Guizhou Provincial 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 5 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 23 Oct 2026. 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 Yong Li, MD (+8613628566285, liyong7229771@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (sensitivity and specificity) of the cfDNA fragmentomics model for early screening of endometrial cancer (time frame: At baseline (time of blood collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07892755, which also lists 3 linked publications.
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 23 Oct 2026.