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2018-08-01
2020-08
2020-09
30
NCT03821909
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OBSERVATIONAL
Acquisition of Portal Venous CTCs and Exosomes From Patients With Pancreatic Cancer by EUS
The investigators are going to explore the diagnostic and prognostic value of circulating tumor cells and exosomes extracted from the portal venous blood obtained with endoscopic ultrasound in pancreatic cancer patients.
As the prognosis of pancreatic cancer, a kind of malignant tumor, remains poor due to the low diagnostic rate at the early stage, there is still a significant clinical need to determine individualized tumor molecular profiles and personalized risk for recurrence. Circulating tumor cells (CTCs) and exosomes from patients with primary tumors may hold promise in serving as an informative biomarker to address this clinical need. Here in this study, the investigators are going to explore the feasibility and safety of sampling portal venous blood via endoscopic ultrasound (EUS), and detect portal venous CTCs and analyze mRNA markers of exosomes by RNA-seq. The investigators aim to explore the potential molecular mechanisms in tumor microenvironment and mechanisms of drug resistance.
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 |
|---|---|---|
2019-01-06 | N/A | 2019-01-29 |
2019-01-26 | N/A | 2019-01-31 |
2019-01-30 | N/A | 2019-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Pancreatic cancer Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology. | PROCEDURE: Endoscopic ultrasound-guided protal venous blood sampling
|
| : Benign pancreatic diseases Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology, e.g. PCLs. | PROCEDURE: Endoscopic ultrasound-guided protal venous blood sampling
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The difference of the amount of circulating tumor cells acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases | In this study, the amount of the circulating tumor cells obtained from portal venous blood of suspected pancreatic masses patients will be determined by analyzing the expression of folate receptors. The investigators will compare the difference of the CTC amount between patients with pancreatic cancer and benign pancreatic diseases. | 08/01/2018-08/01/2020 |
| The difference of the exosomes acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases | Exosomes will be acquisited from portal venous blood of patients with suspected pancreatic masses. Then the total RNA will be extracted from the exosomes. The investigators will compare the expression of certain mRNA markers of the exosomes between patients with pancreatic cancer and benign pancreatic diseases. (The mRNA markers will be selected from RNA-seq results.) | 08/01/2018-08/01/2020 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The difference of the amount of circulating tumor cells between portal venous and peripheral blood | In this study, the amount of the circulating tumor cells obtained from portal venous blood and peripheral blood will be assessed for each patient respectively. The investigators will compare the difference of the CTC amount between portal venous blood and peripheral blood. | 08/01/2018-08/01/2020 |
| The difference of the exosomes between portal venous and peripheral blood | Exosomes will be acquisited from portal venous blood and peripheral blood for each patient. Then the total RNA will be extracted from the exosomes. The investigators will compare the expression of certain mRNA markers of the exosomes between portal venous and peripheral blood for each patient. (The mRNA markers will be selected from RNA-seq results.) | 08/01/2018-08/01/2020 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Shu Zhang, PhD Phone Number: 13770728926 Email: zhangshu19900513@126.com |
Study Contact Backup Name: Ying Lv, PhD Phone Number: 13770755008 Email: lying1999@126.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:
1
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
