Clinical trial NCT04293497: Development of a New Immunochemistry Method Using Antibodies of Proteins Related Pancreatic Cancer
Official title: Clinical Validation of a New Immunochemistry Method Using Antibody of Methionyl-tRNA synthetase1(MARS1) in the Pancreatic Cancer Cell; Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 97
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.
Primary purpose: DIAGNOSTIC

Brief 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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The comparison of sensitivity between conventional staining method and new staining method
timeFrame: 1 year
Secondary outcomes:
measure: The evaluation of correlation index of staining at three type slides
timeFrame: 1 year
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Bundang-gu
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: Gangnam-gu
city: Incheon
country: Korea, Republic of
facility: In Ha University Hospital
state: Jung-gu
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital, Cheonan
state: Namdong-gu
Study officials:
affiliation: Gangnam Severance Hospital, Yonsei University College of Medicine
name: Sung III Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: