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

NCT05531981UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Peking Union Medical College Hospital

Enrollment

350

Start Date

2022-09-20

Completion Date

2024-09-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

detect HPV E7 ctDNA

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Disease-free survival

time from the treatment initiation to disease progression

Time frame: up to three years

Secondary Outcomes

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

Time frame: up to three years

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

Time frame: up to three years

Overall Survival

time from the treatment initiation to death

Time frame: up to three years

Locations

Peking Union Medical College Hospital, Beijing, China

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.