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NCT Number: NCT04293497

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

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).

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA Bundang Medical Center, Seongnam, Bundang-gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Cytology staining

Diagnostic 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

Primary outcomes

  1. 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

Secondary outcomes

  1. The evaluation of correlation index of staining at three type slides

    Time frame: 1 year

    The correlation index of the new staining method will be evaluated at three type slides such as Thinprep, Surepath, and Direct smear.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2020
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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