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Trial record 2 of 226788 for:    ALL

Comparison of DNA Ploidy and Conventional Cytology

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT02921100
First received: September 26, 2016
Last updated: September 29, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Biopsy, Fine-Needle
Procedure: cytology
Procedure: DNA ploidy
Procedure: EUS-FNA
Device: EUS-guided fine needle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: A Prospective Comparison of Digital Image Analysis and Routine Cytology for the Identification of Pancreatic Neoplasia in Patient Undergoing EUS-FNA

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sensitivity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • specificity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • positive predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • negative predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2015
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Procedure: EUS-FNA
All the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step.
Device: EUS-guided fine needle
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
DIA is a form of cytologic analysis that quantifies cellular constituents by using spectro photometric principles and a sister technique to flow cytometry.Quantification of DNA content, chromatin distribution, and nuclear morphology can be determined and suggest features of malignancy
Other Name: digital image analysis
Procedure: EUS-FNA
All the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step.
Device: EUS-guided fine needle

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. who had known or suspected pancreatic malignancy and
  2. in whom the endosonographer deemed the target lesion safe and feasible to allow the necessary study passes.

Exclusion Criteria:

  1. not willing to sign informed consent,
  2. cells obtained from FNA for DNA ploidy test less than 200, and/or
  3. patients do not cooperate with follow-up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02921100

Locations
China, Shanghai
Shanghai Changhai Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
Study Director: Dong Wang, Dr. Digestive endoscopic center of Changhai Hospital
  More Information

Responsible Party: Zhaoshen Li, Director of gastroenterology department, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02921100     History of Changes
Other Study ID Numbers: DNA ploidy and CC 
Study First Received: September 26, 2016
Last Updated: September 29, 2016
Health Authority: China: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on September 30, 2016