Biopsy, Fine-NeedleNCT02921100
Comparison of DNA Ploidy and Conventional Cytology
A study testing cytology, DNA ploidy and EUS-FNA in people with Biopsy, Fine-Needle, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Biopsy, Fine-Needle
- What is being tested?
- cytology, DNA ploidy and EUS-FNA
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who had known or suspected pancreatic malignancy and
- in whom the endosonographer deemed the target lesion safe and feasible to allow the necessary study passes.
Who cannot join
- not willing to sign informed consent,
- cells obtained from FNA for DNA ploidy test less than 200, and/or
- patients do not cooperate with follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Biopsy, Fine-Needle
- Being tested
- cytology, DNA ploidy, EUS-FNA, EUS-guided fine needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytologyProcedure or surgery
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 ploidyProcedure or surgery
Also called digital image analysis
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-FNAProcedure or surgery
All the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step.
EUS-guided fine needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Conventional cytology | Other | Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo a conventional cytology. Receives: Procedure: cytology; Procedure: EUS-FNA; Device: EUS-guided fine needle |
| DNA ploidy test | Other | Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo DNA ploidy test. Receives: Procedure: DNA ploidy; Procedure: EUS-FNA; Device: EUS-guided fine needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test
Measured: 12 months
Secondary outcomes (4)
sensitivity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy
Measured: 12 months
specificity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy
Measured: 12 months
positive predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy
Measured: 12 months
negative predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biopsy, Fine-NeedleStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Dong Wang, Dr., Study director, Digestive endoscopic center of Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921100
- Sponsor's protocol ID
- DNA ploidy and CC
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Digital Image Analysis and Routine Cytology for the Identification of Pancreatic Neoplasia in Patient Undergoing EUS-FNA
- ClinicalTrials.gov ID
- NCT02921100
- Acronym / sponsor ID
- DNA ploidy and CC
- Conditions
- Biopsy, Fine-Needle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2016 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional cytology | Other | Procedure: cytology, Procedure: EUS-FNA, Device: EUS-guided fine needlePatients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo a conventional cytology. |
| DNA ploidy test | Other | Procedure: DNA ploidy, Procedure: EUS-FNA, Device: EUS-guided fine needlePatients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo DNA ploidy test. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- who had known or suspected pancreatic malignancy and
- in whom the endosonographer deemed the target lesion safe and feasible to allow the necessary study passes.
Key exclusion criteria (3 listed)
- not willing to sign informed consent,
- cells obtained from FNA for DNA ploidy test less than 200, and/or
- patients do not cooperate with follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytologyThe 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 or surgery | Conventional cytology |
| DNA ploidyAlso: digital image analysisDIA 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 | Procedure or surgery | DNA ploidy test |
| EUS-FNAAll the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step. | Procedure or surgery | Conventional cytology, DNA ploidy test |
| EUS-guided fine needle | Device | Conventional cytology, DNA ploidy test |
Primary outcome
Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test
Time frame: 12 months
4 secondary outcomes
sensitivity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy
Time frame: 12 months
specificity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy
Time frame: 12 months
positive predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy
Time frame: 12 months
negative predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Wang, Dr. study director
Digestive endoscopic center of Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cytology, DNA ploidy and EUS-FNA in people with Biopsy, Fine-Needle, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.