Comparison of DNA Ploidy and Conventional Cytology

Biopsy, Fine-Needle Clinical Trial

Official title:

A Prospective Comparison of Digital Image Analysis and Routine Cytology for the Identification of Pancreatic Neoplasia in Patient Undergoing EUS-FNA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02921100
• Other study ID #: DNA ploidy and CC
• Status: Active, not recruiting
• Phase: N/A
• First received: September 26, 2016
• Last updated: September 29, 2016
• Start date: January 2015

Study information

• Verified date: September 2016
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Biopsy, Fine-Needle

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test		12 months	No
Secondary	sensitivity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy		12 months	No
Secondary	specificity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy		12 months	No
Secondary	positive predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy		12 months	No
Secondary	negative predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy		12 months	No