Pancreatic CancerNCT03606148
SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Pancreatic Lesions
An observational study of Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The SurePathTM has been approved by the FDA since 1997. Currently, the SurePathTM is used for endometrial cells, body fluids, bronchoscopy aspirates, and thyroid fine needle aspirates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- SurePathTM
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2018to 31 Dec 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients above 18 years of age who underwent EUS-FNA for suspected pancreatic cancer based on imaging fingings.
Who may be able to join
- Patients who signed the agreement after the explanation
- Patients suspected of pancreatic cancer from radiological examinations (CT, MR, ultrasound)
Who cannot join
- Those who did not agree with the study
- Patients older than 18 years of age
- Serious mental patients
- Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, poorly controlled blood sugar)
- Pregnant women
- If EUS is difficult due to previous surgery (Billroth II or TG with R-en-Y)
- Patient with blood clotting abnormality
- If there is a risk of tract seeding after examination
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Sang Hyub Lee, MD. PhD, +82-2-2072-4892, gidoctor@snuh.org
About this study
Official title: A Prospective Comparison of SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Pancreatic Lesions
The SurePathTM has been approved by the FDA since 1997. Currently, the SurePathTM is used for endometrial cells, body fluids, bronchoscopy aspirates, and thyroid fine needle aspirates. There is an advantage that the denaturation is small, the density of the cells is uniform, and the read area is small so that the read time can be shortened. Therefore, investigators plan to apply the SurePathTM test for pancreatic EUS-FNA specimens. Morphological comparative analysis is needed before completely replacing the existing classical smear test method. The aim of this study is to confirm that the SurePathTM is not inferior and is more accurate than the classical smear test.
- Conditions
- Pancreatic Cancer
- Being tested
- SurePathTM
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurePathTMDiagnostic test
In the liquid-phase cytology, a fine-aspirated sample is immediately inserted into a container containing a commercially available preservative solution without a separate slide-smearing procedure and immediately after the fine-needle aspiration.
| Study group | Role | What they receive |
|---|---|---|
| SurePathTM | The subjects are randomly assigned to SurePathTM/Conventional test group at a ratio of 1: 1.
In SurePathTM group, subjects who underwent SurePathTM liquid-phase cytology test with the first sample subjected to the conventional smear test with the second sample. Receives: Diagnostic Test: SurePathTM | |
| Conventional | The subjects are randomly assigned to SurePathTM/Conventional test group at a ratio of 1: 1.
In conventional test group, those who subjected to the conventional smear test with the first sample, will undergo the SurePathTM liquid cell test with the second obtained sample. Receives: Diagnostic Test: SurePathTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
If surgical treatment is performed after the examination, pathologic results of the surgical specimen and record will be checked whether it is malignancy or benign. If benign diagnosis is made by combining the results of SurePathTM and conventional smear test, the follow-up period is 6 months and the results of the 6-month follow-up imaging and additional biopsy are checked. Additional tests performed at this time are subject to the clinician's decision according to the clinical situation of each patient. The combined results make a final diagnosis and are compared between two groups.
Measured: 6 months after randomization
Secondary outcomes (2)
Sensitivity
The proportion of positives that are correctly identified as such.
Measured: 6 months after randomization
Specificity
The proportion of negatives that are correctly identified as such
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start17 Apr 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606148
- Sponsor's protocol ID
- 1803-094-930
- Status last verified
- Apr 2018
- First submitted
- 26 Apr 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chun JW, Lee K, Lee SH, Kim H, You MS, Hwang YJ, Paik WH, Ryu JK, Kim YT. Comparison of liquid-based cytology with conventional smear cytology for EUS-guided FNA of solid pancreatic masses: a prospective randomized noninferiority study. Gastrointest Endosc. 2020 Apr;91(4):837-846.e1. doi: 10.1016/j.gie.2019.11.018. Epub 2019 Nov 20.
PubMed 31759036
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT03606148
- Acronym / sponsor ID
- 1803-094-930
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 30 Jul 2018 (actual)
- 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.
The SurePathTM has been approved by the FDA since 1997. Currently, the SurePathTM is used for endometrial cells, body fluids, bronchoscopy aspirates, and thyroid fine needle aspirates. There is an advantage that the denaturation is small, the density of the cells is uniform, and the read area is small so that the read time can be shortened. Therefore, investigators plan to apply the SurePathTM test for pancreatic EUS-FNA specimens. Morphological comparative analysis is needed before completely replacing the existing classical smear test method. The aim of this study is to confirm that the SurePathTM is not inferior and is more accurate than the classical smear test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SurePathTM | – | Diagnostic Test: SurePathTMThe subjects are randomly assigned to SurePathTM/Conventional test group at a ratio of 1: 1. In SurePathTM group, subjects who underwent SurePathTM liquid-phase cytology test with the first sample subjected to the conventional smear test with the second sample. |
| Conventional | – | Diagnostic Test: SurePathTMThe subjects are randomly assigned to SurePathTM/Conventional test group at a ratio of 1: 1. In conventional test group, those who subjected to the conventional smear test with the first sample, will undergo the SurePathTM liquid cell test with the second obtained sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients above 18 years of age who underwent EUS-FNA for suspected pancreatic cancer based on imaging fingings.
Key inclusion criteria (2 listed)
- Patients who signed the agreement after the explanation
- Patients suspected of pancreatic cancer from radiological examinations (CT, MR, ultrasound)
Key exclusion criteria (8 listed)
- Those who did not agree with the study
- Patients older than 18 years of age
- Serious mental patients
- Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, poorly controlled blood sugar)
- Pregnant women
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 |
|---|---|---|
| SurePathTMIn the liquid-phase cytology, a fine-aspirated sample is immediately inserted into a container containing a commercially available preservative solution without a separate slide-smearing procedure and immediately after the fine-needle aspiration. | Diagnostic test | Conventional, SurePathTM |
Primary outcome
Diagnostic accuracy
Time frame: 6 months after randomization
If surgical treatment is performed after the examination, pathologic results of the surgical specimen and record will be checked whether it is malignancy or benign. If benign diagnosis is made by combining the results of SurePathTM and conventional smear test, the follow-up period is 6 months and the results of the 6-month follow-up imaging and additional biopsy are checked. Additional tests performed at this time are subject to the clinician's decision according to the clinical situation of each patient. The combined results make a final diagnosis and are compared between two groups.
2 secondary outcomes
Sensitivity
Time frame: 6 months after randomization
Specificity
Time frame: 6 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 31759036Chun JW, Lee K, Lee SH, Kim H, You MS, Hwang YJ, Paik WH, Ryu JK, Kim YT. Comparison of liquid-based cytology with conventional smear cytology for EUS-guided FNA of solid pancreatic masses: a prospective randomized noninferiority study. Gastrointest Endosc. 2020 Apr;91(4):837-846.e1. doi: 10.1016/j.gie.2019.11.018. Epub 2019 Nov 20.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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 8 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 23 Jan 2019. 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 South Korea. 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?
Contact Sang Hyub Lee, MD. PhD. (+82-2-2072-4892, gidoctor@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606148, which also lists 1 linked publication.
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 23 Jan 2019.