Clinical trial NCT05531981: Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
Official title: Clinical Value of Minimal Residual Disease Detection Based on Human Papillomavirus Circulating Tumor DNA (HPV ctDNA) in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Obstetrics and Gynecology Hospital
name: Peking University Cancer Hospital & Institute
name: Precision Scientific (Beijing) Co., Ltd
First posted: 2022-09-08
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility 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

Primary outcomes:
measure: Disease-free survival
timeFrame: up to three years
Secondary outcomes:
measure: HPV ctDNA state before treatment
timeFrame: up to three years
measure: Dynamic change trend of HPV ctDNA after treatment
timeFrame: up to three years
measure: Overall Survival
timeFrame: up to three years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: