Cervical CancerNCT06456112
Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV
An observational study of Cervical Cancer, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Systematic evaluation of the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jul 2026
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Cervical cancer patients diagnosed with HPV16 or HPV18 infection
Who may be able to join
- Women, aged between 18 and 75 years, can receive standard treatment, including patients who only receive surgery, and patients who receive radiotherapy and chemotherapy after surgery.
- Cervical cancer caused by HPV16 or HPV18 infection diagnosed by molecular biology or pathological tissue (p16), with pathological stage of IB1 to IV.
- -
Who cannot join
- Patients with other malignancies
- Patients with any uncontrolled systemic disease, including active infection, uncontrolled hypertension, diabetes mellitus, unstable angina and congestive heart failure, myocardial infarction (1 year) before starting treatment, severe arrhythmia requiring medical treatment, coagulation abnormalities, liver or kidney or metabolic disease
- Cervical cancer patients who had undergone LEEP knife or conization in primary hospitals
- Cervical cancer patients whose peripheral blood was negative for ctHPV at baseline. Here, ctHPV negative refers to patients who are both negative for ddPCR and NGS
Trial locations and contacts
1 site in 1 country.
China1 site
Anhui Provincal Hospital
Hefei, Anhui, 230001
Ying Zhou, MD, +8613865901025, caddiezy@ustc.edu.cn
About this study
Systematic evaluation of the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients.
Read the detailed description
Cervical cancer has a very clear etiology, with the vast majority of cases being caused by persistent and repeated infections with high-risk HPV. In the carcinogenic mechanism of cervical cancer, there are large amounts of HR-HPV integrated into the human genome in cancer cells; these HR-HPV can be released into the bloodstream in the form of ctHPV, and most patients with stages I-IV of cervical cancer can have detectable ctHPV in their blood. Among them, the detection rate in the blood of late-stage patients ranges from 63.3% to 100%. Several studies have demonstrated that ctHPV may serve as a marker for monitoring recurrent tumor molecular residual lesions, which could be of significant importance for prognostic evaluation and monitoring whether the disease has recurred. In this study, we will systematically evaluate the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients
- Conditions
- 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.
The one-year probability of OS
OS (overall survival) is defined as the time which begins at diagnosis and up to the time of death
Measured: one year
Secondary outcomes (1)
PFS
progression free survival
Measured: 1 month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ying Zhou, MD, Study chair, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456112
- Sponsor's protocol ID
- YingZhou 2024-7
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV
- ClinicalTrials.gov ID
- NCT06456112
- Acronym / sponsor ID
- YingZhou 2024-7
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 13 Jun 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.
Systematic evaluation of the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients.
Detailed description
Cervical cancer has a very clear etiology, with the vast majority of cases being caused by persistent and repeated infections with high-risk HPV. In the carcinogenic mechanism of cervical cancer, there are large amounts of HR-HPV integrated into the human genome in cancer cells; these HR-HPV can be released into the bloodstream in the form of ctHPV, and most patients with stages I-IV of cervical cancer can have detectable ctHPV in their blood. Among them, the detection rate in the blood of late-stage patients ranges from 63.3% to 100%. Several studies have demonstrated that ctHPV may serve as a marker for monitoring recurrent tumor molecular residual lesions, which could be of significant importance for prognostic evaluation and monitoring whether the disease has recurred. In this study, we will systematically evaluate the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cervical cancer patients diagnosed with HPV16 or HPV18 infection
Key inclusion criteria (3 listed)
- Women, aged between 18 and 75 years, can receive standard treatment, including patients who only receive surgery, and patients who receive radiotherapy and chemotherapy after surgery.
- Cervical cancer caused by HPV16 or HPV18 infection diagnosed by molecular biology or pathological tissue (p16), with pathological stage of IB1 to IV.
- -
Key exclusion criteria (4 listed)
- Patients with other malignancies
- Patients with any uncontrolled systemic disease, including active infection, uncontrolled hypertension, diabetes mellitus, unstable angina and congestive heart failure, myocardial infarction (1 year) before starting treatment, severe arrhythmia requiring medical treatment, coagulation abnormalities, liver or kidney or metabolic disease
- Cervical cancer patients who had undergone LEEP knife or conization in primary hospitals
- Cervical cancer patients whose peripheral blood was negative for ctHPV at baseline. Here, ctHPV negative refers to patients who are both negative for ddPCR and NGS
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
The one-year probability of OS
Time frame: one year
OS (overall survival) is defined as the time which begins at diagnosis and up to the time of death
1 secondary outcome
PFS
Time frame: 1 month post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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.
Ying Zhou, MD study chair
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
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 Cervical Cancer, run by Anhui Provincial 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 3 inclusion and 4 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 1 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 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 Ying Zhou, MD (+8613865901025, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The one-year probability of OS (time frame: one 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 1 Jul 2024.