Uterine Cervical Neoplasms
Conditions
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).
Interventions
OTHERdetect 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
Sponsors
Beijing Obstetrics and Gynecology Hospital
Peking University Cancer Hospital & Institute
Precision Scientific (Beijing) Co., Ltd
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | up to three years | time from the treatment initiation to disease progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall Survival | up to three years | time from the treatment initiation to death |
Countries
China
Contacts
Primary ContactYang Xiang
Outcome results
None listed