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Effects of Different Methods of PDAC Specimen Acquisition on Primary Cell Culture and Application

10 de março de 2021 atualizado por: The Third Xiangya Hospital of Central South University

Different Methods of Pancreatic Ductal Adenocarcinoma Specimen Acquisition, EUS-FNB vs. Surgery, Influence on Culturing Primary Cells to Screen Sensitive Chemotherapeutics for Individuals: a Prospective Cohort Study

The purpose of this study is to investigate the difference in the success rate of culturing primary cells derived from pancreatic ductal adenocarcinoma specimens of patients which obtained by endoscopic ultrasound-guided fine-needle biopsy wet suction technique and surgery, analyze whether the sensitive chemotherapeutic agents screened by the primary cells cultured from the specimens obtained by the above two methods are consistent, and whether they are consistent with the clinical treatment effect of patients, verify the accuracy of laboratory drug sensitivity results, so as to provide the basis for pancreatic ductal adenocarcinoma patients to choose the source of individual treatment samples.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

Pancreatic cancer is one of the malignant tumors with the highest mortality rate in the world, with a 5-year survival rate of only 7.2%-9%. Because some patients are resistant to multiple chemotherapy drugs, and there are differences in drug sensitivity between individuals, the current pancreatic ductal adenocarcinoma (PDAC) chemotherapy effect is not satisfactory. In order to improve the efficacy of chemotherapy and achieve precise treatment, it is important to establish an accurate and individualized PDAC research model.

At present, several studies have reported that surgical specimens of pancreatic cancer are successfully used to cultivate preclinical research models. However, most patients with PDAC have developed to advanced stage at the time of diagnosis and are not suitable for surgery, which limits our ability to obtain tumor cells. Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) can procure specimens when patients have not receive any treatment, and can also evaluate the therapeutic effect and tumor progression in the process of treatment.

Until now, there is no study to compare the efficiency of the two methods in constructing preclinical research model of pancreatic cancer. Therefore, the investigators intend to investigate the difference in the success rate of culturing primary cells derived from PDAC specimens of patients which obtained by EUS-FNB wet suction technique and surgery, analyze whether the sensitive chemotherapeutic agents screened by the primary cells cultured from the specimens obtained by the above two methods are consistent, and whether they are consistent with the clinical treatment effect of patients, verify the accuracy of laboratory drug sensitivity results, so as to provide the basis for PDAC patients to choose the source of individual treatment samples.

Tipo de estudo

Observacional

Inscrição (Antecipado)

20

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recrutamento
        • The Third Xiangya Hospital, Central South University
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients who are considered as PDAC by imaging, and may have opportunity of surgery, and require EUS-FNB for definite diagnosis will potentially be included in this study. Informed consent will be given by the doctor in charge or endoscopic operator or researcher. Patients who agree to participate in the trial will sign an informed consent form. Patients were enrolled after being screened according to the eligibility criteria.

Descrição

Inclusion Criteria:

  1. Male or female, age≥18
  2. Imaging examination (US, MRI, CT or PET-CT) of patients confirmed pancreatic lesions, and considered the possibility of PDAC, EUS-FNB was needed for auxiliary diagnosis
  3. No chemotherapy, including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy, has been performed on patients
  4. Having surgery opportunities (including radical operation and cytoreductive surgery) and willingness of operation
  5. Agree to attend this study and signed informed consent

Exclusion Criteria:

  1. Poor physical condition, including but not limited to hemoglobin ≤ 8.0g/dl, severe cardiopulmonary insufficiency, etc
  2. Coagulation dysfunction (platelet count < 50,000/mm3, international standardized ratio > 1.5), or inability to discontinue anticoagulation therapy
  3. High risk for deep sedation
  4. Acute pancreatitis in the previous 2 weeks
  5. Pregnancy or lactation
  6. Any diseases leading to unreliable follow-up
  7. Absence of informed consent

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
EUS-FNB group
Each patient participated in the EUS-FNB group and the surgery group. The procedure of EUS-FNB with wet suction technique is as follow: before the needle was inserted into the biopsy channel, the stylet was removed, and the needle was flushed with saline solution until the fluid dripped out of the needle tip. The air column was replaced with the fluid. A 10-mL syringe was prefilled with 2 mL of saline solution, and the valve was closed. The syringe was loaded to the 5-mL position (i.e. a 3-mL vacuum) and then attached to the proximal port and used for biopsy after inserting into the biopsy channel and puncturing the lesion. Each patient was performed 1-2 passes to obtain specimens for subsequent experiments.
Procedimento: different methods of specimen acquisition
After informed consent, the investigators use two methods to obtain specimens for patients with pancreatic ductal adenocarcinoma, who needs eus-fnb for auxiliary diagnosis and had the opportunity of surgery. One method is EUS-FNB with wet suction technique, the other is surgery (including radical operation and cytoreductive surgery). Both methods are used on the same patient to remove deviations in results caused by tumor heterogeneity.
surgery group
Each patient participated in the EUS-FNB group and the surgery group. The patient underwent EUS-FNB with wet suction technique first, followed by surgery (palliative surgery without excising tumor is not included) for pancreatic cancer. According to the size of the specimen, 0.5cm3-1cm3 tumor specimen was used for subsequent experiments.
Procedimento: different methods of specimen acquisition
After informed consent, the investigators use two methods to obtain specimens for patients with pancreatic ductal adenocarcinoma, who needs eus-fnb for auxiliary diagnosis and had the opportunity of surgery. One method is EUS-FNB with wet suction technique, the other is surgery (including radical operation and cytoreductive surgery). Both methods are used on the same patient to remove deviations in results caused by tumor heterogeneity.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The different culture success rate
Prazo: About 6 weeks after operation
The difference in the success rate of primary cell culture (P1) and passage to the third generation (P3) between PDAC specimens obtained by EUS-FNB and those obtained by surgery.
About 6 weeks after operation
The representation of the primary cells of pancreatic cancer
Prazo: About 8 weeks after operation
Through Western Blot and PCR methods to detect the representativeness of primary cells to the primary tumor. If the patient underwent surgery later, hematoxylin-eosin staining and/or immunohistochemistry were added to compare the histological morphology with the original tumor.
About 8 weeks after operation

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Differences in drug susceptibility results between the two groups
Prazo: About 14 weeks after operation
The primary cells cultured from PDAC which obtained by two methods, EUS-FNB and surgery, are used to screen sensitive chemotherapeutic drugs commonly used in pancreatic ductal adenocarcinoma, and to see if there are any differences between the two groups.
About 14 weeks after operation
Differences of drug sensitivity results between in vitro and clinical drug results
Prazo: About 22 weeks after operation
The results of the commonly used sensitive chemotherapeutics for pancreatic ductal adenocarcinoma screened by the two groups of primary cells are fed back to the clinician. If the patients have not started chemotherapy, the drug will be used according to the results screened in vitro to observe whether the tumor markers improved and the tumor size decreased. If the patients have completed chemotherapy, the laboratory results are compared with the clinical results of chemotherapy, i.e., whether the in vitro screening results of sensitive/resistant drugs have the same effect in vivo.
About 22 weeks after operation

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Third Xiangya Hospital of Central South University

Investigadores

  • Investigador principal: Xiaoyan Wang, M.D., The Third Xiangya Hospital, Central South University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de janeiro de 2021

Conclusão Primária (Antecipado)

30 de novembro de 2021

Conclusão do estudo (Antecipado)

28 de fevereiro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

1 de março de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de março de 2021

Primeira postagem (Real)

15 de março de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de março de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de março de 2021

Última verificação

1 de março de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2021EUS-002

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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