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2015-01
2016-10
N/A
150
NCT02921100
Changhai Hospital
Changhai Hospital
INTERVENTIONAL
Comparison of DNA Ploidy and Conventional Cytology
150 patients who had suspected pancreatic malignancy were planed to be enrolled in this study. Equal cytological samples of each patient undergoing EUS-FNA were examined by digital image analysis and conventional cytology respectively. The investigators aim to compare the efficacy of DIA and conventional cytology in diagnosing pancreatic cancer. Further more, the investigators also collected the blood sample of each enrolled patient for advanced study.
The conventional cytology was interpreted independently by two cytopathologists, both of whom are blinded to the DIA results. The conventional cytologic diagnosis were classified as no abnormal cells, atypical cells, suspicious malignant cells and malignant cells. The specimens were examined by two experienced cytopathologists. Any disagreement on specimens would refer to a third cytopathologist to provide a final consensus. The former two diagnosis were determined to be positive, and the latter two to be negative. DIA is a form of cytologic analysis that quantifies cellular constituents by using spectro photometric principles and a sister technique to flow cytometry. Computer analysis of the pixels produces a digital image of the nucleus and other cellular constituents. Quantification of DNA content, chromatin distribution, and nuclear morphology can be determined and suggest features of malignancy. ThinPrep specimens were prepared as previously described.Per specimen, the DNA content of at least 500 cells was selected for quantification using an image analyzer (Landing Medical High-tech, Wuhan, Hubei, China) and the mean integrated optical density lymphocytes served as an internal standard control. All other histograms suggesting the presence of (1) any cells with DNA>5c; (2) diploidy cells with a very high proliferation rate where 10% or more of the total cells were found in the proliferation fraction; and (3) a population of aneuploidy stem cells, were called positive for malignancy. Images of cells reporting a DNA amount greater than 5c were examined microscopically by a cytotechnologist to exclude any artifacts such as dust, air bubbles, overlapping cells, etc. from the >5c cell galleries. All the final diagnosis are to be confirmed by histopathology or a long term follow up.
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 |
|---|---|---|
2016-09-26 | N/A | 2016-09-29 |
2016-09-29 | N/A | 2016-09-30 |
2016-09-30 | N/A | 2016-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Conventional cytology Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo a conventional cytology. | PROCEDURE: cytology
PROCEDURE: EUS-FNA
DEVICE: EUS-guided fine needle |
| OTHER: DNA ploidy test Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo DNA ploidy test. | PROCEDURE: DNA ploidy
PROCEDURE: EUS-FNA
DEVICE: EUS-guided fine needle |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test | 12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| sensitivity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy | 12 months | |
| specificity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy | 12 months | |
| positive predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy | 12 months | |
| negative predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy | 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
