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Brief Title: 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 ID: NCT04293497
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.
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHA Bundang Medical Center, Seongnam, Bundang-gu, Korea, Republic of
Gangnam Severance Hospital, Seoul, Gangnam-gu, Korea, Republic of
In Ha University Hospital, Incheon, Jung-gu, Korea, Republic of
Soon Chun Hyang University Hospital, Cheonan, Cheonan, Namdong-gu, Korea, Republic of
Name: Sung III Jang, MD, PhD
Affiliation: Gangnam Severance Hospital, Yonsei University College of Medicine
Role: PRINCIPAL_INVESTIGATOR