Cervical Cancer ScreeningNCT06204133
Model Study on Cervical Cancer Screening Strategies and Risk Prediction
An observational study of Cervical Cancer Screening and Risk Assessment, run by Fujian Maternity and Child Health Hospital at 7 sites in China.
Trial summary
By collecting non-image medical data of women undergoing cervical screening in multiple centers in China, including age, HPV infection status, HPV infection type, TCT results, and colposcopy biopsy pathology results, a multi-source heterogeneous cervical lesion collaborative research big data platform was established. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening, Risk Assessment, Artificial Intelligence
- What is being tested?
- Artificial intelligence model building
- How many people
- 1,112,846 participants
- Where
- 7 sitesChina
- Study dates
- 1 Nov 2023to 30 Jun 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 25 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: For women aged 25-64 years who undergo cervical cancer screening, all women use HR-HPV testing as a primary screening strategy.
Who may be able to join
- Age 25-64 years old;
- There was no history of precancerous lesions or cervical cancer;
- No previous cervical surgery or cervical removal;
Who cannot join
- HPV test results are not available;
- Pregnant or lactating women;
- There is a serious immune system disease, and the disease is active;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Shunde Women's and Children's Hospital of Guangdong Medical University
Foshan, Guangdong
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, 350001
Guiyang maternal and child health care hospital
Guiyang, Guizhou
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Ganshu
Ningde maternal and child health hospital
Ningde, Fujian
Shenzhen Maternal and Child Health Hospital
Shenzhen, Guangdong
Hubei Maternal and Child Health Hospital
Wuhan, Hubei
About this study
By collecting non-image medical data of women undergoing cervical screening in multiple centers in China, including age, HPV infection status, HPV infection type, TCT results, and colposcopy biopsy pathology results, a multi-source heterogeneous cervical lesion collaborative research big data platform was established. Based on artificial intelligence (AI) machine learning, cervical lesion screening features are refined, a multi-modal cervical cancer intelligent screening prediction and risk triage model is constructed, and its clinical application value is preliminarily explored.
Read the detailed description
By collecting non-image medical data of women undergoing cervical screening in multiple centers in China, including age, HPV infection status, HPV infection type, TCT results, and colposcopy biopsy pathology results, a multi-source heterogeneous cervical lesion collaborative research big data platform was established. Based on artificial intelligence (AI) machine learning, cervical lesion screening features are refined, a multi-modal cervical cancer intelligent screening prediction and risk triage model is constructed, and its clinical application value is preliminarily explored. The effect of clinical application of the model was evaluated by internal data from Fujian Province and external data from several other regions in China.
- Being tested
- Artificial intelligence model building
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence model buildingOther
Using non-image medical data of cervical lesions and clinical pathology results in different medical institutions, machine learning is adopted to establish multiple multi-modal cervical cancer intelligent screening prediction models. This method was used to analyze the prediction performance of the multi-modal cervical cancer intelligent screening prediction and risk triage model, and to evaluate and optimize the self-learning ability of the established multi-modal cervical cancer intelligent screening prediction model.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical histopathology
Cervical histopathological diagnosis within 8 weeks
Measured: within 8 weeks，
colposcopy
Colposcopists use colposcopic equipment to investigate the occurrence of cervical and vaginal lesions within 8 weeks
Measured: Percentage of patients diagnosed with cervical intraepithelial neoplasia of grade 3 (CIN3) or worse by cervical histopathological measurements within 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,112,846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pengming Sun, Study chair, Fujian Maternal and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204133
- Sponsor's protocol ID
- CSRM2304
- Status last verified
- Jul 2024
- First submitted
- 15 Dec 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model Study on Cervical Cancer Screening Strategies and Risk Prediction
- ClinicalTrials.gov ID
- NCT06204133
- Acronym / sponsor ID
- CSRM2304
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,112,846 participants (actual)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Jan 2024 (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.
By collecting non-image medical data of women undergoing cervical screening in multiple centers in China, including age, HPV infection status, HPV infection type, TCT results, and colposcopy biopsy pathology results, a multi-source heterogeneous cervical lesion collaborative research big data platform was established. Based on artificial intelligence (AI) machine learning, cervical lesion screening features are refined, a multi-modal cervical cancer intelligent screening prediction and risk triage model is constructed, and its clinical application value is preliminarily explored.
Detailed description
By collecting non-image medical data of women undergoing cervical screening in multiple centers in China, including age, HPV infection status, HPV infection type, TCT results, and colposcopy biopsy pathology results, a multi-source heterogeneous cervical lesion collaborative research big data platform was established. Based on artificial intelligence (AI) machine learning, cervical lesion screening features are refined, a multi-modal cervical cancer intelligent screening prediction and risk triage model is constructed, and its clinical application value is preliminarily explored. The effect of clinical application of the model was evaluated by internal data from Fujian Province and external data from several other regions in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- For women aged 25-64 years who undergo cervical cancer screening, all women use HR-HPV testing as a primary screening strategy.
Key inclusion criteria (3 listed)
- Age 25-64 years old;
- There was no history of precancerous lesions or cervical cancer;
- No previous cervical surgery or cervical removal;
Key exclusion criteria (3 listed)
- HPV test results are not available;
- Pregnant or lactating women;
- There is a serious immune system disease, and the disease is active;
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 |
|---|---|---|
| Artificial intelligence model buildingUsing non-image medical data of cervical lesions and clinical pathology results in different medical institutions, machine learning is adopted to establish multiple multi-modal cervical cancer intelligent screening prediction models. This method was used to analyze the prediction performance of the multi-modal cervical cancer intelligent screening prediction and risk triage model, and to evaluate and optimize the self-learning ability of the established multi-modal cervical cancer intelligent screening prediction model. | Other | – |
Primary outcome
Cervical histopathology
Time frame: within 8 weeks，
Cervical histopathological diagnosis within 8 weeks
colposcopy
Time frame: Percentage of patients diagnosed with cervical intraepithelial neoplasia of grade 3 (CIN3) or worse by cervical histopathological measurements within 8 weeks
Colposcopists use colposcopic equipment to investigate the occurrence of cervical and vaginal lesions within 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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.
Pengming Sun study chair
Fujian Maternal and Child Health Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Screening and Risk Assessment, run by Fujian Maternity and Child Health Hospital at 7 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical histopathology (time frame: within 8 weeks，). 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 22 Jul 2024.