Uterine Cervical NeoplasmNCT04974424
Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV
An observational study of Uterine Cervical Neoplasm and Uterine Cervical Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Most uterine cervical high-risk human papillomavirus (HPV) infections are transient, with only a small fraction developing into cervical cancer. Family aggregation studies and heritability estimates suggest a significant inherited genetic component. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasm, Uterine Cervical Cancer, Cervical Cancer
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Dec 2023
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese population
Who may be able to join
- (1) Case group a) Aged 25-75 years. b) Han nationality. c) Patients with cervical cancer or cervical precancerous lesions above CIN2 diagnosed by biopsy or postoperative pathological diagnosis.
- (2) Control group: a) Aged 25-75 years. b) Han nationality. c) No family history of cervical cancer or precancerous lesions. d) The results of TCT examination showed no abnormality.
Who cannot join
- (1) suffering from other neoplastic diseases.
- (2) pregnant women.
- (3) those with a history of bone marrow transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430000
Ding Ma, MD, 0086-27-8362681, dma@tjh.tjmu.edu.cn
About this study
Official title: Study on Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV
Most uterine cervical high-risk human papillomavirus (HPV) infections are transient, with only a small fraction developing into cervical cancer. Family aggregation studies and heritability estimates suggest a significant inherited genetic component. Candidate gene studies and previous genome-wide association studies (GWASs) report associations between the HLA region and cervical cancer. Adopting a genome-wide approach, we aimed to establish an early warning model for a high-risk population of cervical cancer.
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant loci of genetic variation
The impact of genetic variance on predisposition to cervical cancer
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Obstetrics & Gynecology Hospital of Fudan University, Qilu Hospital of Shandong University, Wuhan Central Hospital, Third Military Medical University, Xiangyang Central Hospital, Shenzhen Second People's Hospital
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Ding Ma, MD, PhD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974424
- Sponsor's protocol ID
- S160
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV
- ClinicalTrials.gov ID
- NCT04974424
- Acronym / sponsor ID
- S160
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Obstetrics & Gynecology Hospital of Fudan University, Qilu Hospital of Shandong University, Wuhan Central Hospital, Third Military Medical University, Xiangyang Central Hospital, Shenzhen Second People's Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Jul 2021 (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.
Most uterine cervical high-risk human papillomavirus (HPV) infections are transient, with only a small fraction developing into cervical cancer. Family aggregation studies and heritability estimates suggest a significant inherited genetic component. Candidate gene studies and previous genome-wide association studies (GWASs) report associations between the HLA region and cervical cancer. Adopting a genome-wide approach, we aimed to establish an early warning model for a high-risk population of cervical cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese population
Key inclusion criteria (2 listed)
- (1) Case group a) Aged 25-75 years. b) Han nationality. c) Patients with cervical cancer or cervical precancerous lesions above CIN2 diagnosed by biopsy or postoperative pathological diagnosis.
- (2) Control group: a) Aged 25-75 years. b) Han nationality. c) No family history of cervical cancer or precancerous lesions. d) The results of TCT examination showed no abnormality.
Key exclusion criteria (3 listed)
- (1) suffering from other neoplastic diseases.
- (2) pregnant women.
- (3) those with a history of bone marrow transplantation.
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
Significant loci of genetic variation
Time frame: 2
The impact of genetic variance on predisposition to cervical cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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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.
Ding Ma, MD, PhD study chair
Huazhong University of Science and Technology
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 Uterine Cervical Neoplasm and Uterine Cervical Cancer, run by Huazhong University of Science and Technology 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 2 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. 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 Ding Ma, MD, PhD (0086-27-836268, dma@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant loci of genetic variation (time frame: 2). 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 23 Jul 2021.