Detection Technology of Peripheral Blood ctDNA Based on CRISPR/Cas and Gold Nanoparticles
This study tests a new, fast blood test that may help detect very small traces of tumor DNA in the bloodstream. When tumor cells die, they release small pieces of DNA called circulating tumor DNA (ctDNA) into the blood. Finding these pieces can help doctors diagnose cancer, monitor how well treatment is working, and detect cancer recurrence earlier. However, ctDNA is present in very small amounts and is hard to detect with current methods. Newer techniques such as next-generation sequencing (NGS) can find ctDNA, but they are expensive, require specialized laboratories, and take days to return results. This study evaluates a new testing method called "CRISPR/Cas12a combined with gold nanoparticle detection." This method uses a gene-editing protein (Cas12a) that can recognize a specific mutation in the BRCA1 gene and a gold nanoparticle-based readout that shows results within about 30 minutes, using portable equipment.
The main purpose of this study is to find out how accurate, sensitive, and specific this new test is compared with NGS, which is considered the gold standard. The study will also check whether the portable device works consistently across different hospitals and whether the test results match patients' responses to treatment.
The study will enroll adult cancer patients treated at participating hospitals and a group of healthy volunteers. All participants will provide about 3 mL of blood (less than one teaspoon). No additional invasive procedures or extra hospital visits are required beyond routine blood draws. For cancer patients, part of the blood sample will be tested with the new method and part will be tested with standard NGS, and the two results will be compared. Healthy volunteers' blood will be used to confirm that the test does not produce false positive results.
There is no direct physical harm from the test itself, since it is performed on blood samples in the laboratory. Participants will receive the ctDNA test free of charge, and their test results may help their doctors better understand their disease.
The results of this study may help develop a rapid, low-cost, bedside test for tumor DNA, which could improve cancer diagnosis and monitoring in the future.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Xiangwen Dong
- Número de telefone: +86 15515997079
- E-mail: dongxiangwen1234@163.com
Locais de estudo
-
-
Henan
-
Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University
-
Contato:
- Tengfei Zhang
- Número de telefone: 15093333574
- E-mail: fcczhangtf@zzu.edu.cn
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population consists of two groups: (1) Cancer patients - adult patients with BRCA1-related tumors (e.g., breast, ovarian, or prostate cancer) receiving care at The First Affiliated Hospital of Zhengzhou University (lead site) and Sir Run Run Shaw Hospital, Zhejiang University (participating site), who agree to provide a peripheral blood sample; and (2) Healthy volunteers - adults without a history of cancer, recruited at the participating hospitals as the control group for specificity assessment. All participants provide written informed consent before enrollment. Participants are recruited based on the principles of voluntariness and fairness, without discrimination by race, gender, or socioeconomic status
Descrição
Inclusion Criteria:
- Adults (≥18 years of age) diagnosed with a malignant tumor at one of the participating hospitals
- Patients willing and able to provide written informed consent
Exclusion Criteria:
- Patients who refuse or are unable to sign the informed consent form
- Patients with severe hematologic or coagulation disorders that make blood collection infeasible
- Healthy volunteers: adults (≥18 years) with no history of cancer, willing to provide written informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Cancer patients
Patients with BRCA1-related tumors (e.g., breast, ovarian, or prostate cancer) enrolled at participating hospitals. Approximately 3 mL of EDTA-anticoagulated peripheral blood is collected from each participant. Each sample is tested by both the investigational CRISPR/Cas12a-gold nanoparticle ctDNA detection method and next-generation sequencing (NGS, the gold standard reference), and the results of the two methods are compared to evaluate diagnostic accuracy and sensitivity. |
|
Healthy Volunteers
Healthy adults without a history of cancer, enrolled as the control group for specificity assessment. Approximately 3 mL of EDTA-anticoagulated peripheral blood is collected from each participant and tested by the CRISPR/Cas12a-gold nanoparticle method to determine the false positive rate. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diagnostic accuracy of the CRISPR/Cas12a-gold nanoparticle ctDNA test compared with NGS
Prazo: through study completion, an average of 1 year
|
The agreement between the CRISPR/Cas12a-gold nanoparticle ctDNA detection method and next-generation sequencing (NGS, the gold standard reference) will be evaluated in tumor patient samples. Diagnostic accuracy is measured by the Kappa coefficient of concordance between the two methods, with Kappa ≥0.85 considered excellent agreement. Sensitivity (detection positive rate of 1 pM, 0.5 pM, and 0.1 pM target ctDNA samples; ≥95% considered qualified) and specificity (false positive rate in 50 healthy volunteer samples; ≤5% considered qualified) will also be assessed. |
through study completion, an average of 1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Stability of the portable detection device across multiple centers
Prazo: through study completion, an average of 1 year
|
Inter-site consistency of the portable device will be assessed by the coefficient of variation (CV) of the same batch of standard samples tested at multiple centers; CV ≤10% is considered qualified. |
through study completion, an average of 1 year
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-KY-0225-003
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .