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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797676
• Other study ID #: 2021EUS-002
• Status: Recruiting
• Start date: January 15, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2021
• Source: The Third Xiangya Hospital of Central South University
• Contact: Xiaoyan Wang, M.D.
• Phone: +8613974889301
• Email: tingtong[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	The Third Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The different culture success rate	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
Primary	The representation of the primary cells of pancreatic cancer	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
Secondary	Differences in drug susceptibility results between the two groups	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
Secondary	Differences of drug sensitivity results between in vitro and clinical drug results	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