Pancreatic Ductal AdenocarcinomaNCT04794140
A Clinical Study to Evaluated Which Number of Passes of EUS-FNB is Better for Culturing Primary Cells of PDAC
A study testing different number of passes in people with Pancreatic Ductal Adenocarcinoma, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- different number of passes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Agree to attend this study and signed informed consent
Who cannot join
- Poor physical condition, including but not limited to hemoglobin ≤ 8.0g/dl, severe cardiopulmonary insufficiency, etc
- Coagulation dysfunction (platelet count < 50 × 1012, 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital, Central South University,
Changsha, Hunan, 410013
Xiaoyan Wang, M.D., +8613974889301, tingtong@csu.edu.cn
Ting Tong, M.D., +8613247360862, 89588355@163.com
About this study
Official title: A Randomized Controlled, Blinded, Prospective Clinical Study Evaluating the Effect of Endoscopic Ultrasound-guided Fine-needle Biopsy With Different Number of Passes on the Success Rate of Primary Cell Culture of Pancreatic Cancer
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
Read the detailed 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.
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- different number of passes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different number of passesProcedure or surgery
Each patient's operation process is the same, that is, after obtaining enough specimens for diagnosis by endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique, additional three passes are performed. One of which is randomly selected as the one pass group, and the other two passes automatically as the two pass group. Please refer to the literature for EUS-FNB wet technique (Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.)
| Study group | Role | What they receive |
|---|---|---|
| one pass group | Experimental | 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 Gastroenterol Hepatol. 2020;10.1111/jgh.15371. Receives: Procedure: different number of passes |
| two passes group | Experimental | 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 Gastroenterol Hepatol. 2020;10.1111/jgh.15371. Receives: Procedure: different number of passes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: About 8 weeks after operation
Secondary outcomes (1)
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.
Measured: About 6 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start15 Jan 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoyan Wang, M.D., Principal investigator, The Third Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794140
- Sponsor's protocol ID
- 2021EUS-001
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Blinded, Prospective Clinical Study Evaluating the Effect of Endoscopic Ultrasound-guided Fine-needle Biopsy With Different Number of Passes on the Success Rate of Primary Cell Culture of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04794140
- Acronym / sponsor ID
- 2021EUS-001
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one pass group | Experimental | Procedure: different number of passesWe 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 Gastroenterol Hepatol. 2020;10.1111/jgh.15371. |
| two passes group | Experimental | Procedure: different number of passesWe 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 Gastroenterol Hepatol. 2020;10.1111/jgh.15371. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Agree to attend this study and signed informed consent
Key exclusion criteria (7 listed)
- Poor physical condition, including but not limited to hemoglobin ≤ 8.0g/dl, severe cardiopulmonary insufficiency, etc
- Coagulation dysfunction (platelet count < 50 × 1012, 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different number of passesEach patient's operation process is the same, that is, after obtaining enough specimens for diagnosis by endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique, additional three passes are performed. One of which is randomly selected as the one pass group, and the other two passes automatically as the two pass group. Please refer to the literature for EUS-FNB wet technique (Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.) | Procedure or surgery | one pass group, two passes group |
Primary outcome
Differences in the success rate of culturing primary cells
Time frame: About 6 weeks after operation
Differences in the success rate of pancreatic cancer primary cells (P1) and culture to the third generation (P3) between the two groups.
The difference in the representation to the original tumor between the two groups of primary cells
Time frame: 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.
1 secondary outcome
The relationship between the success rate of primary cell culture and some tumor characteristics
Time frame: About 6 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyan Wang, M.D. principal investigator
The Third Xiangya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different number of passes in people with Pancreatic Ductal Adenocarcinoma, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Wang, M.D. (+8613974889301, tingtong@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the success rate of culturing primary cells (time frame: About 6 weeks after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.