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Trial Title:
Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
NCT ID:
NCT05531981
Condition:
Uterine Cervical Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Neoplasm, Residual
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
detect HPV E7 ctDNA
Description:
Peripheral blood was collected from the patients, and the copy number of HPV E7 gene in
ctDNA was accurately detected by ddPCR
Arm group label:
initial concurrent chemoradiotherapy group
Arm group label:
initial surgical treatment group
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).
Criteria for eligibility:
Study pop:
Cohort A: Patients with cervical cancer who were initially treated with surgery in Peking
Union Medical College Hospital, Peking University Cancer Hospital and Beijing Obstetrics
and Gynecology Hospital, capital Medical University were enrolled in this study.
Cohort B: Patients who were initially treated with concurrent chemoradiotherapy in Peking
Union Medical College Hospital, Peking University Cancer Hospital and Beijing Obstetrics
and Gynecology Hospital, capital Medical University were enrolled in this study.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Xiang
Phone:
01069156068
Email:
XiangY@pumch.cn
Start date:
September 20, 2022
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Obstetrics and Gynecology Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Precision Scientific (Beijing) Co., Ltd
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05531981
