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2021-01-15
2021-10-31
2022-01-31
60
NCT04794140
The Third Xiangya Hospital of Central South University
The Third Xiangya Hospital of Central South University
INTERVENTIONAL
A Clinical Study to Evaluated Which Number of Passes of EUS-FNB is Better for Culturing Primary Cells of PDAC
The Aim of this study is to investigate the amount of tissue required for the successful culture of primary cells from human-derived pancreatic ductal adenocarcinoma which obtained by endoscopic ultrasound-guided fine-needle biopsy wet suction technique
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. Because most of patients with PDAC have developed to advanced stage at the time of diagnosis, it is not suitable for surgery. That limits our ability to obtain tumor cells seriously. With the development of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) technique, it can be used not only to diagnose diseases, but also to provide specimens for molecular analysis and create valuable preclinical disease research models, so as to guide the selection of the most appropriate individualized treatment. EUS-FNB can obtain lesions without any treatment. Therefore, the preclinical disease research model established by EUS-FNB is more representative of the original tumor. However, compared with surgical specimens, the specimens obtained by EUS-FNB are smaller in size, which may affect the successful construction of research models in vitro. Therefore, the investigators plan to use EUS-FNB wet suction technique, a modified specimen acquisition method, to obtain PDAC tissue, and use it for primary cell culture, to explore the amount of tissue required for the successful cultivation of human-derived pancreatic cancer primary cells, so as to provide a prerequisite for the successful establishment of human-derived preclinical disease research model.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-03-01 | N/A | 2021-03-10 |
2021-03-10 | N/A | 2021-03-11 |
2021-03-11 | N/A | 2021-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: one pass group We use the endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique to procure the specimens, and use the sample obtained from a single pass for primary cell culture. EUS-FNB wet suction technique refer from Tong T, et al. J Gastroe | PROCEDURE: different number of passes
|
| EXPERIMENTAL: two passes group We use the endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique to procure the specimens, and use the sample obtained from two passes for primary cell culture. EUS-FNB wet suction technique refer from Tong T, et al. J Gastroente | PROCEDURE: different number of passes
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Differences in the success rate of culturing primary cells | Differences in the success rate of pancreatic cancer primary cells (P1) and culture to the third generation (P3) between the two groups. | About 6 weeks after operation |
| The difference in the representation to the original tumor between the two groups of primary cells | 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The relationship between the success rate of primary cell culture and some tumor characteristics | Statistical methods such as chi-square test are used to analyze whether the success rate of primary cell culture is related to the tumor size, degree of differentiation, clinical stage, and the length of macroscopic visible core tissue. | About 6 weeks after operation |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xiaoyan Wang, M.D. Phone Number: +8613974889301 Email: tingtong@csu.edu.cn |
Study Contact Backup Name: Ting Tong, M.D. Phone Number: +8613247360862 Email: 89588355@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
