Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
A Prospective Study on the Application of Low-Depth Circulating Free DNA Fragmentomics in Monitoring Recurrence and Guiding Therapy for Cervical Cancer
This is a prospective, single-center, observational cohort study that plans to enroll 100 women aged 18 years or older with histologically confirmed cervical cancer who are scheduled to receive radical surgery, radiotherapy, or systemic therapy. The study aims to establish and validate a low-depth cfDNA fragmentomics approach-including tumor fraction, fragment length distribution, and copy number variation-together with cfHPV-DNA testing for monitoring recurrence risk and predicting treatment response. Serial blood samples (10 mL per collection) will be obtained before initial treatment, 1-4 weeks after standardized treatment, at 3 and 6 months, and every 3 months thereafter until 2 years after treatment completion or until an endpoint event; fresh or paraffin-embedded tumor tissue will also be collected for whole-exome sequencing and multi-omics analysis. The study will not alter participants' routine clinical treatment. Research-related risks are mainly blood draw-related discomfort, bleeding, or bruising; risks from standard radiotherapy, chemotherapy, or immunotherapy are part of routine clinical care and are not introduced by this observational study. Privacy and confidentiality risks will be minimized through informed consent, secure data storage, restricted database access, and confidential handling of records. cfDNA testing will be provided free of charge, and appropriate compensation may be provided based on participation and time commitment. The study is funded by 3D Medicines (Shanghai) Co., Ltd.; conflict-of-interest, data/sample-sharing, and intellectual property arrangements will be disclosed and managed according to institutional requirements.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Peking Union Medical College Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
This single-center prospective observational cohort will enroll 100 adult women aged ≥18 years with histologically confirmed cervical cancer (including squamous cell carcinoma, adenocarcinoma, and other subtypes) who are planned to receive radical treatment with surgery, radiotherapy, and/or systemic therapy and who can provide complete clinical and follow-up data. Participants will undergo serial blood and tumor tissue collection before and after standard treatment for low-depth cfDNA fragmentomics and cfHPV-DNA analysis. Patients with a history of other malignancies (except cured skin basal cell carcinoma), severe hepatic/renal insufficiency, coagulation disorders, active infection, pregnancy or breastfeeding, inability to cooperate with follow-up or sample collection, or prior systemic therapy for cervical cancer (except neoadjuvant therapy) will be excluded. Routine clinical treatment is not altered.
Descrição
Inclusion Criteria:
- Female aged 18 years or older.
- Histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma, and other subtypes.
- Planned to receive radical treatment, including surgery, radiotherapy, or chemotherapy.
- Voluntarily agrees to participate and signs the informed consent form.
- Able to provide complete clinical and follow-up information for the study.
Exclusion Criteria:
- A history of other malignancies (except cured tumors such as basal cell carcinoma of the skin).
- Severe hepatic or renal insufficiency, coagulation disorders, or active infection.
- Pregnancy or breastfeeding.
- Inability to cooperate with follow-up or sample collection.
- Prior systemic therapy for cervical cancer (except neoadjuvant therapy).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Objective response rate
Prazo: From initiation of primary treatment through 2 years after completion of treatment or until an endpoint event (recurrence, progression, or death), whichever occurs first; final analysis at study completion.
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From initiation of primary treatment through 2 years after completion of treatment or until an endpoint event (recurrence, progression, or death), whichever occurs first; final analysis at study completion.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- K9926
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