Endometrial CancerNCT06083779
Early Detection of Endometrial Cancer Using Plasma Cell-free DNA Fragmentomics
An observational study of Endometrial Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to enable non-invasive early detection of endometrial cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- low-depth whole-genome sequencing technology
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 108 early to mid-stage endometrial cancer patients and 108 non-cancer controls
Who may be able to join
- Age minimum 18 years
- Patients diagnosed with early to mid-stage endometrial cancer (more than 50% are in FIGO stages I/II) through histological and/or cytological examination.
- Ability to understand and the willingness to sign a written informed consent document
- Participants can obtain comprehensive clinical and pathological information.
- Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening
Who cannot join
- Participants must not be pregnant or breastfeeding
- Participants must not have prior cancer histories or a second non-endometrial malignancy
- Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
- Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
- Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
- Participants with clinically important abnormalities or conditions unsuitable for blood collection
- Any other disease or clinical condition of participants that the researcher believes may affect the compliance of the protocol, or affect the patient's signing of the informed consent form (ICF), which is not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Bingzhong Zhang, MD, 13925063030 ext. 86, 13925063030@163.com
About this study
Official title: A Prospective Study of Early Detection of Endometrial Cancer Using Plasma Cell-free DNA Fragmentomics
The purpose of this study is to enable non-invasive early detection of endometrial cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage endometrial cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five different feature types, including Fragment Size Distribution, nucleosome features, SBS Signatures, BreakPoint Motif , and Copy Number Variation will be assessed to generate this model.
Read the detailed description
Currently, there is no international consensus on the standard for endometrial cancer screening. The Expert Committee on Endometrial Cancer Screening in China released the "Expert Consensus on Endometrial Cancer Screening and Early Diagnosis (Draft)" in 2017, recommending the use of endometrial brushes for endometrial sampling and the use of endometrial cytology for slide preparation. Transvaginal ultrasound (TVS) can be used as an initial assessment and auxiliary method for endometrial cytology screening for endometrial cancer. For women without clinical symptoms, the routine method of endometrial cancer screening is mainly TVS to monitor endometrial thickness. Although TVS has high sensitivity, its specificity is very low, with a low positive predictive value (PPV) and a high false-positive rate, making it unable to distinguish between benign and malignant endometrial changes. There are also certain operator subjective judgments and instrument-related errors. For women with clinical symptoms, patients need endometrial cytology testing, that is, invasive endometrial sampling with an endometrial brush, followed by cytological slide preparation. Suspicious malignant tumor cells or malignant tumor cells should immediately undergo hysteroscopy and segmental diagnostic curettage to obtain endometrial biopsy tissue, and further clinical treatment should be carried out based on the pathological results. Due to the need to go deep into the uterus, the sampling failure rate for nulliparous women is as high as 20%, and the sampling failure rate for multiparous women is 8%. Whether it is endometrial cytology or hysteroscopic biopsy, which is close to the invasive operation of abortion, it will bring a lot of pain and economic burden to women. Moreover, there are currently no specific and sensitive tumor markers available for the diagnosis and follow-up of endometrial cancer. Therefore, it is urgent to develop a non-invasive, efficient screening detection method.
In short, the space for early screening of endometrial cancer is vast, and liquid biopsy is non-invasive, convenient and easy to accept. It is an important technical means for early screening research of endometrial cancer, and has great potential to improve the performance of early screening of endometrial cancer. In order to further verify the application value of cfDNA-based fragmentomics in early screening of endometrial cancer and better screen the high-risk population of endometrial cancer in China, this study intends to analyze the characteristics of five cfDNA fragments based on low-depth whole-genome sequencing technology (WGS), and integrate artificial intelligence machine learning technology to establish a prediction model for early screening of endometrial cancer based on cfDNA.
- Conditions
- Endometrial Cancer
- Being tested
- low-depth whole-genome sequencing technology
- Keywords
- Endometrial Cancer, Early Stage, Plasma Cell-free DNA, Fragmentomic assay
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-depth whole-genome sequencing technologyGenetic
the characteristics of five cfDNA fragments based on low-depth whole-genome sequencing technology (WGS)
| Study group | Role | What they receive |
|---|---|---|
| Patients with endometrial cancer | the 108 patients with early to mid-stage endometrial cancer, more than 50% were in FIGO stages I/II. Receives: Genetic: low-depth whole-genome sequencing technology | |
| healthy people | 108 healthy people Receives: Genetic: low-depth whole-genome sequencing technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve of the model for detecting endometrial cancer
The area under curve of the model for the ultrasensitive early detection of endometrial cancer would be evaluate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Aug 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- 216 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc.
- Responsible party
- Sponsor
- Investigators
- Bingzhong Zhang, MD, Principal investigator, The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083779
- Sponsor's protocol ID
- SYSKY-2023-848-01
- Status last verified
- Aug 2023
- First submitted
- 9 Oct 2023
- Last updated
- 16 Oct 2023
- 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 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Early Detection of Endometrial Cancer Using Plasma Cell-free DNA Fragmentomics
- ClinicalTrials.gov ID
- NCT06083779
- Acronym / sponsor ID
- SYSKY-2023-848-01
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Early Stage, Plasma Cell-free DNA, Fragmentomic assay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc.
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 16 Oct 2023 (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.
The purpose of this study is to enable non-invasive early detection of endometrial cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage endometrial cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five different feature types, including Fragment Size Distribution, nucleosome features, SBS Signatures, BreakPoint Motif , and Copy Number Variation will be assessed to generate this model.
Detailed description
Currently, there is no international consensus on the standard for endometrial cancer screening. The Expert Committee on Endometrial Cancer Screening in China released the "Expert Consensus on Endometrial Cancer Screening and Early Diagnosis (Draft)" in 2017, recommending the use of endometrial brushes for endometrial sampling and the use of endometrial cytology for slide preparation. Transvaginal ultrasound (TVS) can be used as an initial assessment and auxiliary method for endometrial cytology screening for endometrial cancer. For women without clinical symptoms, the routine method of endometrial cancer screening is mainly TVS to monitor endometrial thickness. Although TVS has high sensitivity, its specificity is very low, with a low positive predictive value (PPV) and a high false-positive rate, making it unable to distinguish between benign and malignant endometrial changes. There are also certain operator subjective judgments and instrument-related errors. For women with clinical symptoms, patients need endometrial cytology testing, that is, invasive endometrial sampling with an endometrial brush, followed by cytological slide preparation. Suspicious malignant tumor cells or malignant tumor cells should immediately undergo hysteroscopy and segmental diagnostic curettage to obtain endometrial biopsy tissue, and further clinical treatment should be carried out based on the pathological results. Due to the need to go deep into the uterus, the sampling failure rate for nulliparous women is as high as 20%, and the sampling failure rate for multiparous women is 8%. Whether it is endometrial cytology or hysteroscopic biopsy, which is close to the invasive operation of abortion, it will bring a lot of pain and economic burden to women. Moreover, there are currently no specific and sensitive tumor markers available for the diagnosis and follow-up of endometrial cancer. Therefore, it is urgent to develop a non-invasive, efficient screening detection method.
In short, the space for early screening of endometrial cancer is vast, and liquid biopsy is non-invasive, convenient and easy to accept. It is an important technical means for early screening research of endometrial cancer, and has great potential to improve the performance of early screening of endometrial cancer. In order to further verify the application value of cfDNA-based fragmentomics in early screening of endometrial cancer and better screen the high-risk population of endometrial cancer in China, this study intends to analyze the characteristics of five cfDNA fragments based on low-depth whole-genome sequencing technology (WGS), and integrate artificial intelligence machine learning technology to establish a prediction model for early screening of endometrial cancer based on cfDNA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with endometrial cancer | – | Genetic: low-depth whole-genome sequencing technologythe 108 patients with early to mid-stage endometrial cancer, more than 50% were in FIGO stages I/II. |
| healthy people | – | Genetic: low-depth whole-genome sequencing technology108 healthy people |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 108 early to mid-stage endometrial cancer patients and 108 non-cancer controls
Key inclusion criteria (5 listed)
- Age minimum 18 years
- Patients diagnosed with early to mid-stage endometrial cancer (more than 50% are in FIGO stages I/II) through histological and/or cytological examination.
- Ability to understand and the willingness to sign a written informed consent document
- Participants can obtain comprehensive clinical and pathological information.
- Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening
Key exclusion criteria (7 listed)
- Participants must not be pregnant or breastfeeding
- Participants must not have prior cancer histories or a second non-endometrial malignancy
- Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
- Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
- Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
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 |
|---|---|---|
| low-depth whole-genome sequencing technologythe characteristics of five cfDNA fragments based on low-depth whole-genome sequencing technology (WGS) | Genetic | Patients with endometrial cancer, healthy people |
Primary outcome
Area under curve of the model for detecting endometrial cancer
Time frame: 1 year
The area under curve of the model for the ultrasensitive early detection of endometrial cancer would be evaluate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- 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. This study is not recruiting at the moment.
Bingzhong Zhang, MD principal investigator
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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: status not confirmed, as of the sponsor's last update on 16 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingzhong Zhang, MD (13925063030 ext. 86, 13925063030@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve of the model for detecting endometrial cancer (time frame: 1 year). 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 16 Oct 2023.