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

NCT05950087 | Recruiting

• 1 other identifier: (2023)089
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (10)

• Expression levels of MRD

  Blood collected by patients prior to concurrent chemoradiotherapy were tested to observe the expression levels of MRD

  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

  Before chemoradiotherapy

• Expression levels of MRD

  Blood collected in concurrent chemoradiotherapy were examined to observe the expression levels of MRD

  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

  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

  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

  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

  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

  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

  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

  24 weeks after the end of concurrent chemoradiotherapy

Interventions

Concurrent chemoradiotherapy OTHER

Concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed cervical cancer patients who initially visited Guizhou Provincial People's Hospital from November 2022 to November 2024

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guizhou Provincial People's Hospital: lead

Study Sites (1)

Yong Li

Guiyang, Guizhou, China

RECRUITING

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Yong Li, Chief physician

CONTACT

13628566285; liyong7229771@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 18, 2023
• Study Start: November 1, 2022
• Primary Completion: November 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)