Effects of Different Methods of PDAC Specimen Acquisition on Primary Cell Culture and Application
10 mars 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
20
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Hunan
-
Changsha, Hunan, Chine, 410013
- Recrutement
- The Third Xiangya Hospital, Central South University
-
Contact:
- Xiaoyan Wang, M.D.
- Numéro de téléphone: +8613974889301
- E-mail: tingtong@csu.edu.cn
-
Contact:
- Ting Tong, M.D.
- Numéro de téléphone: +8613247360862
- E-mail: 89588355@163.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
Inclusion Criteria:
- Male or female, age≥18
- 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
- No chemotherapy, including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy, has been performed on patients
- Having surgery opportunities (including radical operation and cytoreductive surgery) and willingness of operation
- Agree to attend this study and signed informed consent
Exclusion Criteria:
- Poor physical condition, including but not limited to hemoglobin ≤ 8.0g/dl, severe cardiopulmonary insufficiency, etc
- Coagulation dysfunction (platelet count < 50,000/mm3, international standardized ratio > 1.5), or inability to discontinue anticoagulation therapy
- High risk for deep sedation
- Acute pancreatitis in the previous 2 weeks
- Pregnancy or lactation
- Any diseases leading to unreliable follow-up
- Absence of informed consent
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The different culture success rate
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Differences in drug susceptibility results between the two groups
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Xiaoyan Wang, M.D., The Third Xiangya Hospital, Central South University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 janvier 2021
Achèvement primaire (Anticipé)
30 novembre 2021
Achèvement de l'étude (Anticipé)
28 février 2022
Dates d'inscription aux études
Première soumission
1 mars 2021
Première soumission répondant aux critères de contrôle qualité
10 mars 2021
Première publication (Réel)
15 mars 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 mars 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 mars 2021
Dernière vérification
1 mars 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021EUS-002
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .