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IHC single marker with reporting - Cytokeratin 34 Beta E12 (HMWCK), FFPE Tissue

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Tumor marker staining.

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IHC Single Marker with Reporting - Cytokeratin 34 Beta E12 (HMWCK) FFPE Tissue

  • Why is it done?
    • Distinguishes high-grade dysplasia (HGD) from invasive carcinoma in esophageal and other gastrointestinal tissues
    • Identifies basal layer involvement and helps determine carcinoma invasiveness in Barrett's esophagus
    • Assists in characterizing squamous cell carcinomas and differentiating epithelial tissue origins
    • Performed on formalin-fixed, paraffin-embedded (FFPE) tissue samples obtained from biopsies or resections
    • Helps guide clinical management and prognosis assessment in patients with suspicious or known dysplastic lesions
  • Normal Range
    • Result Interpretation: Qualitative (Positive/Negative) with semi-quantitative scoring
    • Negative Result (Normal): No staining or minimal staining confined to basal epithelial layer; indicates intact basal layer architecture
    • Positive Result (Abnormal): Diffuse or suprabasal staining indicates loss of normal basal layer restriction; suggests invasive carcinoma or severe dysplasia
    • Staining Intensity Score: Typically reported as 0 (negative), 1+ (weak), 2+ (moderate), or 3+ (strong)
    • Percentage of Cells Stained: Reported as percentage of immunoreactive cells; >5-10% in suprabasal region generally indicates abnormality
  • Interpretation
    • Negative/Basal Restriction: Staining limited to basal layer indicates normal tissue architecture; argues against invasive carcinoma; benign or low-grade dysplasia
    • Positive/Loss of Basal Restriction: Diffuse suprabasal immunoreactivity suggests loss of normal stratification and epithelial maturation; indicates invasive carcinoma
    • Focal/Borderline Positivity: Limited areas of suprabasal staining may indicate high-grade dysplasia; requires correlation with histological features and clinical context
    • Clinical Correlation Essential: Results must be interpreted alongside routine histopathology, tissue location, and clinical presentation
    • Factors Affecting Results: Tissue fixation quality, processing artifacts, antibody specificity, background staining in inflammatory cells, and technical variations
    • Barrett's Esophagus Significance: Positive results help identify progression from metaplasia to dysplasia to adenocarcinoma
  • Associated Organs
    • Primary Sites: Esophagus, stomach, colon, rectum, and other gastrointestinal epithelial tissues
    • Associated Conditions - Esophageal: Barrett's esophagus with dysplasia, esophageal adenocarcinoma, squamous cell carcinoma
    • Associated Conditions - Gastric: Gastric adenocarcinoma, intestinal metaplasia with dysplasia
    • Associated Conditions - Colorectal: Colonic adenocarcinoma, high-grade dysplasia in inflammatory bowel disease
    • Disease Detection: Identifies invasive carcinoma versus in-situ lesions; crucial for treatment planning and prognosis
    • Clinical Implications: Positive results may indicate need for more aggressive intervention, endoscopic resection consideration, or surgical management
    • Complication Risk: Invasive carcinoma identified may lead to metastatic disease, local invasion, and compromised patient outcomes if not managed appropriately
  • Follow-up Tests
    • Recommended Complementary IHC Markers: p53, Ki-67, p16 to assess dysplasia grade and molecular changes in Barrett's esophagus
    • Additional Markers if Positive: CK7, CK20, CDX2 for adenocarcinoma characterization and primary site determination
    • Imaging Studies: Endoscopic ultrasound, CT imaging, or PET scan if invasive carcinoma confirmed for staging and metastasis assessment
    • Surveillance Protocol: Repeat endoscopy and biopsies every 3-12 months depending on dysplasia grade if no invasive disease identified
    • Barrett's Esophagus Management: Endoscopic mucosal resection (EMR) or radiofrequency ablation (RFA) if high-grade dysplasia confirmed
    • Molecular Testing: Gene expression profiling or DNA sequencing if available to further risk stratify dysplastic lesions
    • Repeat Biopsies: Additional sampling from different esophageal segments if initial biopsy shows ambiguous or borderline findings
  • Fasting Required?
    • Fasting: No
    • Explanation: This is an immunohistochemistry test performed on fixed tissue samples; fasting is not applicable as no blood draws or active metabolic tests are involved
    • Prior Procedures: Tissue sample obtained via endoscopic biopsy typically requires standard NPO (nothing by mouth) fasting of 6-8 hours before endoscopy procedure
    • Medications: No medication restrictions for the IHC test itself; anticoagulants (warfarin, aspirin) or NSAIDs may need management per protocol if biopsy obtained
    • Special Instructions: Ensure tissue is properly fixed in formalin and embedded in paraffin blocks; proper specimen labeling and documentation required
    • Laboratory Processing: No special patient preparation needed beyond standard tissue handling protocols; test performed on histology slides by laboratory technicians

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