Examining the link between plasma MRD and HPV DNA in advanced cervical cancer treatment outcomes

Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy

This study is testing if measuring certain markers in the blood can help predict how well treatment works for people with advanced cervical cancer.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Guizhou Provincial People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guiyang, Guizhou)
• Trial ID: NCT05950087 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between plasma minimal residual disease (MRD) and circulating free DNA (cfDNA) from HPV in patients with locally advanced cervical cancer undergoing concurrent chemoradiotherapy. By utilizing liquid biopsy techniques, the study aims to analyze the expression levels of MRD and plasma HPV before and after treatment to predict the efficacy of the therapy and assess the risk of disease recurrence. The findings could provide insights into the prognostic value of these biomarkers in managing cervical cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 75 with confirmed locally advanced cervical cancer who are in good physical condition and have measurable lesions.

Not a fit: Patients with severe acute infections, uncontrolled chronic conditions, or allergies to rubber products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to predict treatment outcomes and recurrence risk in cervical cancer patients, leading to more personalized treatment strategies.

How similar studies have performed: While the use of ctDNA as a biomarker in cancer prognosis is gaining traction, this specific approach focusing on MRD and HPV in cervical cancer is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion criteria

* 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.
* 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

Exclusion Criteria:

* 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

Where this trial is running

Guiyang, Guizhou

• Yong Li — Guiyang, Guizhou, China (Recruiting)

Study contacts

• Study coordinator: Yong Li, Chief physician

Conditions Locally Advanced Cervical Cancer