Comparison of DNA Ploidy and Conventional Cytology

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

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.

Study Overview

• Status: Unknown
• Conditions: Biopsy, Fine-Needle
• Intervention / Treatment: Procedure: cytology; Procedure: EUS-FNA; Device: EUS-guided fine needle; Procedure: DNA ploidy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Shanghai Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

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; 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
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: 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; 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 Names: digital image analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test	12 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Study Director: Dong Wang, Dr., Digestive endoscopic center of Changhai Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: DNA ploidy and CC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO