Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer

Recruiting

• Conditions: Uterine Cervical Neoplasms
• Interventions: Other: detect HPV E7 ctDNA

• Registration Number: NCT05531981
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

In this study, a large-scale cohort of cervical cancer patients was established in multiple centers. Minimal residual disease(MRD) was assessed by ddPCR detection of HPV E7 gene ctDNA to assess tumor burden and predict the risk of disease recurrence, so as to provide new biomarkers for precise treatment of cervical cancer patients. The study continued until 36 months after the end of treatment.

Detailed Description

The purpose of this study is to assess MRD by detecting HPV E7 gene ctDNA to assess tumor burden and predict the risk of disease recurrence. According to the treatment methods, the patients were divided into two groups :(1) initial surgical treatment group (2) initial concurrent chemoradiotherapy group.

After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary.

Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, after treatment, and at 6, 12, 18, 24, 30, and 36 months of follow-up.

The primary endpoint is Disease-free survival (DFS, time from the treatment initiation to disease progression). Secondary endpoints include HPV ctDNA state before treatment, dynamic change trend of HPV ctDNA after treatment and overall survival (OS, time from the treatment initiation to death).

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-09-04
• Study First Submitted QC: 2022-09-04
• Study First Posted: 2022-09-08
• Study Start: 2022-09-20
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13
• Primary Completion: 2024-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

• Pathological diagnosis: cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma
• FIGO stage: IA2-IVA
• HPV typing: type 16 or 18
• ECOG 2-0
• The initial treatment was surgery (Cohort A) / concurrent chemoradiotherapy (Cohort B)

Exclusion Criteria

• The diagnosis of cervical cancer was made within 3 years of other malignancies
• Pregnant or lactating women
• Refused to sign a consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
initial concurrent chemoradiotherapy group	detect HPV E7 ctDNA	After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary. Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, 1 month after radiotherapy and at 6, 12, 18, 24, 30, and 36 months of follow-up.
initial surgical treatment group	detect HPV E7 ctDNA	After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary. Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, 2 weeks after surgery, (1 month after adjuvent radiotherapy if available) and at 6, 12, 18, 24, 30, and 36 months of follow-up.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	up to three years	time from the treatment initiation to disease progression

Secondary Outcome Measures

Name	Time	Method
Overall Survival	up to three years	time from the treatment initiation to death
HPV ctDNA state before treatment	up to three years	Peripheral blood was collected from the patients before treatment (surgery or chemotherapy), and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR
Dynamic change trend of HPV ctDNA after treatment	up to three years	Peripheral blood was collected from the patients after treatment ((2 weeks after surgery), 1 month after radiotherapy and at 6, 12, 18, 24, 30, and 36 months of follow-up), and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China