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

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Diagnostic Test: Cytology staining

Study type: Interventional

Funder types: Other

Identifiers

NCT04293497

3-2019-0410

Details and patient eligibility

About

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).

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

Pancreatic Cancer

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Cytology staining