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

Uterine Cervical Neoplasms Clinical Trial

Official title:

Clinical Value of Minimal Residual Disease Detection Based on Human Papillomavirus Circulating Tumor DNA (HPV ctDNA) in Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531981
• Other study ID #: CC-MRD-1
• Status: Recruiting
• Start date: September 20, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: August 2022
• Source: Peking Union Medical College Hospital
• Contact: Yang Xiang
• Phone: 010-69156068
• Email: XiangY[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm, Residual
• Uterine Cervical Neoplasms

Intervention

Other:
• detect HPV E7 ctDNA
Peripheral blood was collected from the patients, and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Obstetrics and Gynecology Hospital, Peking University Cancer Hospital & Institute, Precision Scientific (Beijing) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	time from the treatment initiation to disease progression	up to three years
Secondary	HPV ctDNA state before treatment	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	up to three years
Secondary	Dynamic change trend of HPV ctDNA after treatment	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	up to three years
Secondary	Overall Survival	time from the treatment initiation to death	up to three years