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2020-11-01
2021-11-01
2022-11-01
102
NCT04636788
Huazhong University of Science and Technology
Huazhong University of Science and Technology
INTERVENTIONAL
Circulating Extracellular Exosomal Small RNA as Potential Biomarker for Human Pancreatic Cancer
This study is for the verification of biomarkers for pancreatic cancer treatment using small RNA liquid biopsy, combined with EUS-FNA tissues.
CA19-9 is the FDA approved biomarker for the diagnosis of pancreatic cancer. However, the specificity of CA19-9 to differentiate between pancreatic cancer, cholangiocarcinoma, or other pancreatic lesions is not satisfying enough. Tumor cells secret abundant exosomes in the early stage. Circulating tumor cells are detected mainly in the advanced stage. Meanwhile, the role of non-coding RNA draws more and more attention in tumor area. Exosomes protect inside RNA from plasma RNase. Compared with long RNA, small RNA, including miRNA, snoRNA, tRNA, piRNA could exist more stably. By means of next-generation sequencing, we look forward to finding new exosomal small RNA biomarkers.
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 |
|---|---|---|
2020-11-04 | N/A | 2020-11-14 |
2020-11-14 | N/A | 2020-11-19 |
2020-11-19 | N/A | 2020-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: pancreatic cancer group pancreatic cancer, anticipated participants: 68 other pancreatic lesions including MCN, SCN, IPMN, SPN without malignant pathological finding chronic pancreatitis cholangiocarcinoma healthy control anticipated participants: 34 | PROCEDURE: Venous sampling
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| senstivity | sensitivity of exo-sRNA | up to 8 weeks |
| specificity | specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions | up to 8 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| survival time | relationship between expression level of chosen exosomal RNA and patients' survival time in PAAD group | up to 18 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Bin Cheng, Professor Phone Number: 13986097542 Email: b.cheng@tjh.tjmu.edu.cn |
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
