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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2025
  • participants needed
    350
  • sponsor
    Peking Union Medical College Hospital
Updated on 20 October 2022
carcinoma
squamous cell carcinoma
chemoradiotherapy
adenosquamous carcinoma
adenocarcinoma

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).

Details
Condition Uterine Cervical Neoplasms
Treatment detect HPV E7 ctDNA
Clinical Study IdentifierNCT05531981
SponsorPeking Union Medical College Hospital
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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
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