Pancreatic CancerNCT04293497
Development of a New Immunochemistry Method Using Antibodies of Proteins Related Pancreatic Cancer
A study testing Cytology staining in people with Pancreatic Cancer, run by Gangnam Severance Hospital at 4 sites in South Korea.
Trial summary
Identifying the malignancy of pancreatic mass using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is important for treatment decision-making and prognosis prediction. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cytology staining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 17 Feb 2020to 2 Jul 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pancreatic cancer confirmed by imaging (CT, MRI, PET-CT)
- Patients with pancreatic cancer diagnosed using cytology by endoscopic ultrasound
- Patients who underwent surgical treatment with pancreatic cancer
Who cannot join
- Minors under the age of 19, vulnerable subjects such as illiteracy
- Excludes necrotic specimens
- Samples with non-diagnostic cytology results and insufficient cells for further evaluation
- Samples classified as neoplastic (benign or other)
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Soon Chun Hyang University Hospital, Cheonan
Cheonan, Namdong-gu, 31151
In Ha University Hospital
Incheon, Jung-gu, 22332
CHA Bundang Medical Center
Seongnam, Bundang-gu, 13496
Gangnam Severance Hospital
Seoul, Gangnam-gu, 06229
About this study
Official title: Clinical Validation of a New Immunochemistry Method Using Antibody of Methionyl-tRNA synthetase1(MARS1) in the Pancreatic Cancer Cell; Multicenter Prospective Study
Identifying the malignancy of pancreatic mass using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is important for treatment decision-making and prognosis prediction. The sensitivity of EUS-FNA cytology specimens based on Papanicolaou (Pap) staining is low, which hampers accurate diagnosis of pancreatic mass. We assessed the diagnostic value of immunohistochemical (IHC) and immunofluorescence (IF) staining for methionyl-tRNA synthetase 1 (MARS1).
Read the detailed description
BACKGROUND / AIMS: The sensitivity of endoscopic ultrasound-guided aspiration cytology used to distinguish the pancreatic mass is low and clinical usefulness is not secured. The aim of this study was to evaluate clinical efficacy of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using pancreatic cancer related protein expressed only in pancreatic cancer.
Hypothesis: The statistical significance between conventional staining method and MARS1 staining in the pancreatic cancer cells collected by endoscopic ultrasound-guided aspiration will be compared to prove the usefulness of the new staining method.
Clinical study design: The expression of MARS1 in the pancreatic cancer cell line obtained by endoscopic ultrasound in patients suspected of having pancreatic cancer using Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.
- Conditions
- Pancreatic Cancer
- Being tested
- Cytology staining
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology stainingDiagnostic test
Two staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained using endoscopic ultrasound-guided fine needle aspiration. Three types of slides (direct smear, thinprep, surepath) are prepared for staining.
- conventional cytology staining method
- new cytology staining method using antibody of methionyl-tRNA synthetase 1
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer | Experimental | This arm includes patients with pancreatic cancer. Cytology specimens will be obtained with endoscopic ultrasound-guided fine-needle aspiration in patients with pancreatic cancer. Cytology staining will be performed in the cytology specimens. Receives: Diagnostic Test: Cytology staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of sensitivity between conventional staining method and new staining method
The sensitivity of new staining method will be compared with the conventional Pap staining of endoscopic ultrasound-guided fine-needle aspiration cytology
Measured: 1 year
Secondary outcomes (1)
The evaluation of correlation index of staining at three type slides
The correlation index of the new staining method will be evaluated at three type slides such as Thinprep, Surepath, and Direct smear.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start17 Feb 2020
- Primary completion12 May 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung III Jang, Gangnam Severance Hospital
- Investigators
- Sung III Jang, MD, PhD, Principal investigator, Gangnam Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293497
- Sponsor's protocol ID
- 3-2019-0410
- Status last verified
- Aug 2021
- First submitted
- 29 Feb 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the following individual participant data with other researchers during study period. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a New Immunochemistry Method Using Antibody of Methionyl-tRNA synthetase1(MARS1) in the Pancreatic Cancer Cell; Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT04293497
- Acronym / sponsor ID
- 3-2019-0410
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 3 Mar 2020 (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.
Identifying the malignancy of pancreatic mass using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is important for treatment decision-making and prognosis prediction. The sensitivity of EUS-FNA cytology specimens based on Papanicolaou (Pap) staining is low, which hampers accurate diagnosis of pancreatic mass. We assessed the diagnostic value of immunohistochemical (IHC) and immunofluorescence (IF) staining for methionyl-tRNA synthetase 1 (MARS1).
Detailed description
BACKGROUND / AIMS: The sensitivity of endoscopic ultrasound-guided aspiration cytology used to distinguish the pancreatic mass is low and clinical usefulness is not secured. The aim of this study was to evaluate clinical efficacy of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using pancreatic cancer related protein expressed only in pancreatic cancer.
Hypothesis: The statistical significance between conventional staining method and MARS1 staining in the pancreatic cancer cells collected by endoscopic ultrasound-guided aspiration will be compared to prove the usefulness of the new staining method.
Clinical study design: The expression of MARS1 in the pancreatic cancer cell line obtained by endoscopic ultrasound in patients suspected of having pancreatic cancer using Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer | Experimental | Diagnostic Test: Cytology stainingThis arm includes patients with pancreatic cancer. Cytology specimens will be obtained with endoscopic ultrasound-guided fine-needle aspiration in patients with pancreatic cancer. Cytology staining will be performed in the cytology specimens. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pancreatic cancer confirmed by imaging (CT, MRI, PET-CT)
- Patients with pancreatic cancer diagnosed using cytology by endoscopic ultrasound
- Patients who underwent surgical treatment with pancreatic cancer
Key exclusion criteria (4 listed)
- Minors under the age of 19, vulnerable subjects such as illiteracy
- Excludes necrotic specimens
- Samples with non-diagnostic cytology results and insufficient cells for further evaluation
- Samples classified as neoplastic (benign or other)
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 |
|---|---|---|
| Cytology stainingTwo staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained using endoscopic ultrasound-guided fine needle aspiration. Three types of slides (direct smear, thinprep, surepath) are prepared for staining. 1. conventional cytology staining method 2. new cytology staining method using antibody of methionyl-tRNA synthetase 1 | Diagnostic test | Pancreatic Cancer |
Primary outcome
The comparison of sensitivity between conventional staining method and new staining method
Time frame: 1 year
The sensitivity of new staining method will be compared with the conventional Pap staining of endoscopic ultrasound-guided fine-needle aspiration cytology
1 secondary outcome
The evaluation of correlation index of staining at three type slides
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: Yes. We plan to share the following individual participant data with other researchers during study period. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
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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.
Sung III Jang, MD, PhD principal investigator
Gangnam Severance Hospital, Yonsei University College of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytology staining in people with Pancreatic Cancer, run by Gangnam Severance Hospital at 4 sites 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The comparison of sensitivity between conventional staining method and new staining method (time frame: 1 year). 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 13 Aug 2021.