Development of a New Immunochemistry Method Using Antibodies of Proteins Related Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Clinical Validation of a New Immunochemistry Method Using Antibody of Methionyl-tRNA synthetase1(MARS1) in the Pancreatic Cancer Cell; Multicenter Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293497
• Other study ID #: 3-2019-0410
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: July 2, 2021

Study information

• Verified date: August 2021
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: July 2, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Patients with pancreatic cancer confirmed by imaging (CT, MRI, PET-CT)

2. Patients with pancreatic cancer diagnosed using cytology by endoscopic ultrasound

3. Patients who underwent surgical treatment with pancreatic cancer

Exclusion Criteria:

1. Minors under the age of 19, vulnerable subjects such as illiteracy

2. Excludes necrotic specimens

3. Samples with non-diagnostic cytology results and insufficient cells for further evaluation

4. Samples classified as neoplastic (benign or other)

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• Cytology staining
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

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital, Cheonan	Cheonan	Namdong-gu
Korea, Republic of	In Ha University Hospital	Incheon	Jung-gu
Korea, Republic of	CHA Bundang Medical Center	Seongnam	Bundang-gu
Korea, Republic of	Gangnam Severance Hospital	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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.	1 year