Locally Advanced Cervical CancerNCT05950087
Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy
An observational study of Locally Advanced Cervical Cancer, run by Guizhou Provincial People's Hospital at 1 site in China.
Trial summary
Cervical cancer CC is the most common malignant tumor in the female reproductive system, seriously endangering women's health and life, and is one of the leading causes of death for women worldwide.Globally, HPV causes about 85% of cervical cancers and about 60% of oropharyngeal cancers, causing more than 500,000… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Concurrent chemoradiotherapy
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 2026
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed cervical cancer patients who initially visited Guizhou Provincial People's Hospital from November 2022 to November 2024
Who may be able to join
- Age: ≥ 18 years old, ≤ 75 years old.
- Pathological histologic confirmation of cervical cancer.
- Imaging or PET/CT examination can be performed to understand the tumor and complete all follow-up.
- Measurable lesions before treatment.
- Good physical condition: ECOG score 0-1 (or KPS score 70-100).
- Estimated survival≥ 6 months.
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- The baseline blood routine and biochemical indexes before radiotherapy and chemotherapy met the following standards: hemoglobin ≥ 80g/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT, AST ≤ 2.5 times the normal upper limit; Serum albumin ≥ 30 g/L.
- There are three preoperative items: if the patient has syphilis, plum repellent therapy is required before treatment.
- The patient has no history of allergy to rubber products.
- Cardiopulmonary function is basically normal
Who cannot join
- Those who are allergic to rubber products.
- Those with severe acute infection and uncontrolled or purulent and chronic infection wounds that do not heal, chronic hepatitis B active stage, active tuberculosis, syphilis outbreak and AIDS.
- Patients with pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and intractable hypertension.
- Those with neurological or psychiatric diseases or mental disorders that are not easy to control, poor compliance, unable to cooperate with and describe treatment responses, uncontrolled primary brain tumors or central nervous system metastases, and those with obvious cranial hypertension signs or neuropsychiatric symptoms.
- with malignant serous effusion.
- History of severe enteritis and cystitis, bleeding, intestinal perforation, rectovaginal fistula, rectoval bladder fistula, etc.
- Those who have participated in other clinical trials.
- Other situations in which the investigator believes that the subject is not suitable to participate in this experiment
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
Yong Li
Guiyang, Guizhou
Yong Li, 13628566285, liyong7229771@163.com
About this study
Cervical cancer CC is the most common malignant tumor in the female reproductive system, seriously endangering women's health and life, and is one of the leading causes of death for women worldwide.Globally, HPV causes about 85% of cervical cancers and about 60% of oropharyngeal cancers, causing more than 500,000 cancers each year.ctDNA is a potential biomarker because it contains tumor-specific genetic and epigenetic abnormalities that can be used in cancer diagnosis and prognosis prediction.MRD is considered a promising prognostic marker that can be used to identify individuals at increased risk of recurrence and individuals who may benefit from treatment.The expression level of MRD and plasma HPV before and after radiotherapy and chemotherapy for cervical cancer was analyzed by liquid biopsy ctDNA detection technology, which predicted the efficacy of cervical cancer radiotherapy and chemotherapy, which was helpful for monitoring and estimating the risk of disease recurrence after cervical cancer radiotherapy and chemotherapy, and verified the expression of MRD and plasma HPV as the basis for adjuvant chemotherapy after cervical cancer radiotherapy and the basis for optimal chemotherapy time node selection.
Read the detailed description
Current treatments for cervical cancer include surgery, radiotherapy, chemotherapy, and immunotherapy. However,5 year survival remains unsatisfactory because most patients with cervical cancer are typically diagnosed locally advanced or have distant lymph node metastases.HPV can integrate its own genome into the host genome by disrupting the open reading frame of the E2 gene and increase the expression of the E6 and E7 genes. The p53 protein of the host cell is degraded by the production of the E6 virulent protein, which inactivates the pRb protein that controls the cell cycle, thereby cancerizing the entire host cell [6]. According to TCGA 2017 data, HPV integration into the host genome was found in more than 80% of HPV-positive cervical cancer patients. Han K et al. found that HPV testing can assess the prognosis of cervical cancer patients.Circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), circulating tumor RNA (ctRNA), exosomes, proteins, and metabolites that are liquid biopsy analytes can be identified using biomarkers such as somatic point mutations, deletions, amplification, gene fusion, DNA methylation markers, miRNAs, proteins, or metabolites.Minimal tumor residual (MRD) refers to the residual tumor cells or biomarkers in the body after local or systemic cancer treatment, the activation of which can promote tumor metastasis and recurrence, also known as minimal residual disease, measurable residual disease, and molecular residual disease.Recently, the use of ctDNA analysis to determine MRD in solid tumors after intention-to-treat treatment and before clinical or radiological disease recurrence has shown significant therapeutic promise. In addition, MRD identification by ctDNA analysis correlates with poor prognosis in patients with malignant tumors.This project will use liquid biopsy ctDNA detection technology to analyze the expression level of MRD and plasma HPV before and after radiotherapy and chemotherapy for cervical cancer, predict the efficacy of radiotherapy and chemotherapy for cervical cancer, help monitor and estimate the risk of disease recurrence after radiotherapy and chemotherapy for cervical cancer, verify the expression of MRD and plasma HPV as the basis for adjuvant chemotherapy after radiotherapy and chemotherapy for cervical cancer and the basis for the selection of the optimal chemotherapy time, so as to provide clinically useful tumor markers for cervical cancer patients and reduce the mortality rate of cervical cancer.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Concurrent chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent chemoradiotherapyOther
Concurrent chemoradiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of MRD
Blood collected by patients prior to concurrent chemoradiotherapy were tested to observe the expression levels of MRD
Measured: Before chemoradiotherapy
Positive expression of plasma HPV
Tissue samplescollected by patients prior to concurrent chemoradiotherapy were tested to observe the positive expression of plasma HPV
Measured: Before chemoradiotherapy
Expression levels of MRD
Blood collected in concurrent chemoradiotherapy were examined to observe the expression levels of MRD
Measured: During concurrent chemoradiotherapy, up to 6 weeks
Positive expression of plasma HPV
Tissue samples collected in concurrent chemoradiotherapy were examined to observe the positive expression of plasma HPV
Measured: During concurrent chemoradiotherapy,up to 6 weeks
Expression levels of MRD
Blood collected 4 weeks after the end of concurrent chemoradiotherapy were tested to observe the expression levels of MRD
Measured: 4 weeks after the end of concurrent chemoradiotherapy
Positive expression of plasma HPV
Tissue samples collected 4 weeks after the end of concurrent chemoradiotherapy were tested to observe the positive expression of plasma HPV
Measured: 4 weeks after the end of concurrent chemoradiotherapy
Expression levels of MRD
Blood collected 12 weeks after the end of concurrent chemoradiotherapy were tested to observe the expression levels of MRD
Measured: 12 weeks after the end of concurrent chemoradiotherapy
Positive expression of plasma HPV
Blood and tissue samples collected 12 weeks after the end of concurrent chemoradiotherapy were tested to observe the positive expression of plasma HPV
Measured: 12 weeks after the end of concurrent chemoradiotherapy
Expression levels of MRD
Blood and tissue samples collected by patients 24 weeks after the end of concurrent chemoradiotherapy were tested to observe the expression levels of MRD
Measured: 24 weeks after the end of concurrent chemoradiotherapy
Positive expression of plasma HPV
Blood and tissue samples collected by patients 24 weeks after the end of concurrent chemoradiotherapy were tested to observe the positive expression of plasma HPV
Measured: 24 weeks after the end of concurrent chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Nov 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950087
- Sponsor's protocol ID
- (2023)089
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2023
- Last updated
- 18 Jul 2023
- 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 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05950087
- Acronym / sponsor ID
- (2023)089
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guizhou Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jul 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.
Cervical cancer CC is the most common malignant tumor in the female reproductive system, seriously endangering women's health and life, and is one of the leading causes of death for women worldwide.Globally, HPV causes about 85% of cervical cancers and about 60% of oropharyngeal cancers, causing more than 500,000 cancers each year.ctDNA is a potential biomarker because it contains tumor-specific genetic and epigenetic abnormalities that can be used in cancer diagnosis and prognosis prediction.MRD is considered a promising prognostic marker that can be used to identify individuals at increased risk of recurrence and individuals who may benefit from treatment.The expression level of MRD and plasma HPV before and after radiotherapy and chemotherapy for cervical cancer was analyzed by liquid biopsy ctDNA detection technology, which predicted the efficacy of cervical cancer radiotherapy and chemotherapy, which was helpful for monitoring and estimating the risk of disease recurrence after cervical cancer radiotherapy and chemotherapy, and verified the expression of MRD and plasma HPV as the basis for adjuvant chemotherapy after cervical cancer radiotherapy and the basis for optimal chemotherapy time node selection.
Detailed description
Current treatments for cervical cancer include surgery, radiotherapy, chemotherapy, and immunotherapy. However,5 year survival remains unsatisfactory because most patients with cervical cancer are typically diagnosed locally advanced or have distant lymph node metastases.HPV can integrate its own genome into the host genome by disrupting the open reading frame of the E2 gene and increase the expression of the E6 and E7 genes. The p53 protein of the host cell is degraded by the production of the E6 virulent protein, which inactivates the pRb protein that controls the cell cycle, thereby cancerizing the entire host cell [6]. According to TCGA 2017 data, HPV integration into the host genome was found in more than 80% of HPV-positive cervical cancer patients. Han K et al. found that HPV testing can assess the prognosis of cervical cancer patients.Circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), circulating tumor RNA (ctRNA), exosomes, proteins, and metabolites that are liquid biopsy analytes can be identified using biomarkers such as somatic point mutations, deletions, amplification, gene fusion, DNA methylation markers, miRNAs, proteins, or metabolites.Minimal tumor residual (MRD) refers to the residual tumor cells or biomarkers in the body after local or systemic cancer treatment, the activation of which can promote tumor metastasis and recurrence, also known as minimal residual disease, measurable residual disease, and molecular residual disease.Recently, the use of ctDNA analysis to determine MRD in solid tumors after intention-to-treat treatment and before clinical or radiological disease recurrence has shown significant therapeutic promise. In addition, MRD identification by ctDNA analysis correlates with poor prognosis in patients with malignant tumors.This project will use liquid biopsy ctDNA detection technology to analyze the expression level of MRD and plasma HPV before and after radiotherapy and chemotherapy for cervical cancer, predict the efficacy of radiotherapy and chemotherapy for cervical cancer, help monitor and estimate the risk of disease recurrence after radiotherapy and chemotherapy for cervical cancer, verify the expression of MRD and plasma HPV as the basis for adjuvant chemotherapy after radiotherapy and chemotherapy for cervical cancer and the basis for the selection of the optimal chemotherapy time, so as to provide clinically useful tumor markers for cervical cancer patients and reduce the mortality rate of cervical cancer.
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
- Diagnosed cervical cancer patients who initially visited Guizhou Provincial People's Hospital from November 2022 to November 2024
Key inclusion criteria (10 listed)
- Age: ≥ 18 years old, ≤ 75 years old.
- Pathological histologic confirmation of cervical cancer.
- Imaging or PET/CT examination can be performed to understand the tumor and complete all follow-up.
- Measurable lesions before treatment.
- Good physical condition: ECOG score 0-1 (or KPS score 70-100).
Key exclusion criteria (8 listed)
- Those who are allergic to rubber products.
- Those with severe acute infection and uncontrolled or purulent and chronic infection wounds that do not heal, chronic hepatitis B active stage, active tuberculosis, syphilis outbreak and AIDS.
- Patients with pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and intractable hypertension.
- Those with neurological or psychiatric diseases or mental disorders that are not easy to control, poor compliance, unable to cooperate with and describe treatment responses, uncontrolled primary brain tumors or central nervous system metastases, and those with obvious cranial hypertension signs or neuropsychiatric symptoms.
- with malignant serous effusion.
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 |
|---|---|---|
| Concurrent chemoradiotherapyConcurrent chemoradiotherapy | Other | – |
Primary outcome
Expression levels of MRD
Time frame: Before chemoradiotherapy
Blood collected by patients prior to concurrent chemoradiotherapy were tested to observe the expression levels of MRD
Positive expression of plasma HPV
Time frame: Before chemoradiotherapy
Tissue samplescollected by patients prior to concurrent chemoradiotherapy were tested to observe the positive expression of plasma HPV
Expression levels of MRD
Time frame: During concurrent chemoradiotherapy, up to 6 weeks
Blood collected in concurrent chemoradiotherapy were examined to observe the expression levels of MRD
Positive expression of plasma HPV
Time frame: During concurrent chemoradiotherapy,up to 6 weeks
Tissue samples collected in concurrent chemoradiotherapy were examined to observe the positive expression of plasma HPV
Expression levels of MRD
Time frame: 4 weeks after the end of concurrent chemoradiotherapy
Blood collected 4 weeks after the end of concurrent chemoradiotherapy were tested to observe the expression levels of MRD
Positive expression of plasma HPV
Time frame: 4 weeks after the end of concurrent chemoradiotherapy
Tissue samples collected 4 weeks after the end of concurrent chemoradiotherapy were tested to observe the positive expression of plasma HPV
Expression levels of MRD
Time frame: 12 weeks after the end of concurrent chemoradiotherapy
Blood collected 12 weeks after the end of concurrent chemoradiotherapy were tested to observe the expression levels of MRD
Positive expression of plasma HPV
Time frame: 12 weeks after the end of concurrent chemoradiotherapy
Blood and tissue samples collected 12 weeks after the end of concurrent chemoradiotherapy were tested to observe the positive expression of plasma HPV
Expression levels of MRD
Time frame: 24 weeks after the end of concurrent chemoradiotherapy
Blood and tissue samples collected by patients 24 weeks after the end of concurrent chemoradiotherapy were tested to observe the expression levels of MRD
Positive expression of plasma HPV
Time frame: 24 weeks after the end of concurrent chemoradiotherapy
Blood and tissue samples collected by patients 24 weeks after the end of concurrent chemoradiotherapy were tested to observe the positive expression of plasma HPV
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 18 Jul 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.
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 Locally Advanced Cervical Cancer, 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 10 inclusion and 8 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 18 Jul 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?
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, Chief physician (13628566285, liyong7229771@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of MRD (time frame: Before chemoradiotherapy). The study lists 10 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 18 Jul 2023.