- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04797676
Effects of Different Methods of PDAC Specimen Acquisition on Primary Cell Culture and Application
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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Werving
- The Third Xiangya Hospital, Central South University
-
Contact:
- Xiaoyan Wang, M.D.
- Telefoonnummer: +8613974889301
- E-mail: tingtong@csu.edu.cn
-
Contact:
- Ting Tong, M.D.
- Telefoonnummer: +8613247360862
- E-mail: 89588355@163.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The different culture success rate
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Differences in drug susceptibility results between the two groups
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Xiaoyan Wang, M.D., The Third Xiangya Hospital, Central South University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2021EUS-002
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Ductaal adenocarcinoom van de alvleesklier
-
Andrei IagaruNiet meer beschikbaarCarcinoïde tumoren | Eilandcel (Pancreatic NET) | Andere neuro-endocriene tumorenVerenigde Staten