Clinical trial NCT06456112: Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV
Official title: Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-13
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cervical cancer patients diagnosed with HPV16 or HPV18 infection

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Cervical cancer caused by HPV16 or HPV18 infection diagnosed by molecular biology or pathological tissue (p16), with pathological stage of IB1 to IV.

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Exclusion Criteria:

1. Patients with other malignancies
2. 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
3. Cervical cancer patients who had undergone LEEP knife or conization in primary hospitals
4. 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

Primary outcomes:
measure: The one-year probability of OS
timeFrame: one year
Secondary outcomes:
measure: PFS
timeFrame: 1 month post treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincal Hospital
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Ying Zhou, MD
role: STUDY_CHAIR
References: