IHC single marker with reporting CD117

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Tumor marker staining.

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IHC Single Marker with Reporting CD117 - Comprehensive Guide

Why is it done?
- Detection and diagnosis of gastrointestinal stromal tumors (GISTs) - CD117 is a marker for c-KIT proto-oncogene expression, which is commonly overexpressed in GISTs
- Differentiation of GISTs from other mesenchymal tumors and smooth muscle neoplasms
- Assessment of mast cell disorders and mastocytosis - CD117 is expressed on mast cells and their precursors
- Evaluation of certain hematologic malignancies and acute myeloid leukemias (AML) with CD117 expression
- Identification of germ cell tumors and testicular neoplasms that may express CD117
- Typically performed on formalin-fixed, paraffin-embedded (FFPE) tissue samples obtained from biopsies or surgical specimens
- Ordered when histologic morphology alone is inconclusive or when tissue origin requires clarification
Normal Range
- Negative Result: CD117 is expressed in normal tissue in a limited, specific distribution pattern. Absence of CD117 staining or staining limited to normal interstitial cells of Cajal in gastrointestinal samples
- Units of Measurement: The test is reported qualitatively as Positive or Negative, and semiquantitatively graded by intensity (0 to 3+) and percentage of cells staining
- Positive Result: Strong membranous and/or cytoplasmic staining in tumor cells indicates CD117 expression. Diffuse staining pattern is typical in GISTs and mast cell neoplasms
- Scoring System: Results typically reported as: • 0: No staining • 1+: Weak staining in <25% of cells • 2+: Moderate staining in 25-75% of cells • 3+: Strong staining in >75% of cells
- Normal vs. Abnormal: Abnormal indicates CD117 overexpression in the tissue, which is consistent with neoplastic process or myeloproliferative disorder
Interpretation
- Positive CD117 Staining (Strong 3+): Strongly suggestive of gastrointestinal stromal tumor (GIST) when found in spindle cell or epithelioid mesenchymal tumors of the GI tract. Supports diagnosis of systemic mastocytosis or other mast cell disorders. May indicate expression in certain hematologic malignancies or germ cell tumors depending on clinical context
- Positive CD117 Staining (Moderate 2+): Consistent with GIST diagnosis but should be interpreted with morphologic findings and other immunohistochemical markers. May indicate precursor mast cell involvement or intermediate grade neoplasm
- Positive CD117 Staining (Weak 1+): Requires careful interpretation; should be correlated with morphology and clinical presentation. May represent borderline case or limited expression pattern
- Negative CD117 Staining (0): Makes GIST diagnosis less likely in the context of mesenchymal tumors but does not exclude it entirely. Suggests alternative diagnoses such as leiomyoma, leiomyosarcoma, or other sarcomas. CD117-negative GISTs are rare but documented
- Factors Affecting Interpretation: Tissue fixation quality and processing may affect staining intensity. Specimen adequacy is critical; scant or necrotic tissue may yield inconclusive results. Location and morphology of staining (cytoplasmic vs. membranous) should be assessed. Results should always be interpreted with morphologic findings and clinical context
- Clinical Significance: CD117 positivity has therapeutic implications - GISTs with CD117 expression respond to tyrosine kinase inhibitors (imatinib, sunitinib). Prognostic value depends on combination with other markers (DOG1, CD34) and clinical features. Pattern and intensity of staining can help establish tissue origin and guide further diagnostic workup
Associated Organs
- Primary Organ Systems Involved: • Gastrointestinal tract (stomach, small intestine, colon) - most common site for GISTs • Hematologic/Lymphoid system - mast cells, bone marrow, lymph nodes • Soft tissues and mesenchymal tissues - peritoneal surfaces, omentum, mesentery
- Diseases Associated with Abnormal CD117 Results: • Gastrointestinal stromal tumors (GISTs) - most important association • Systemic mastocytosis and indolent mastocytosis • Acute myeloid leukemia (AML) with CD117 expression • Germ cell tumors and testicular seminomas • Interstitial cell tumors • Some cases of leiomyosarcoma with CD117 coexpression
- Potential Complications of Abnormal Results: • GISTs carry risk of metastatic disease and peritoneal dissemination • Systemic mastocytosis can involve multiple organ systems including skin, bone, liver, and spleen • Hematologic malignancies with CD117 expression may require immediate intervention • Risk of hemorrhage or obstruction from large GISTs in GI tract • Increased morbidity and mortality associated with high-grade tumors
- Related Pathophysiology: CD117 (c-KIT) is a tyrosine kinase receptor involved in cellular proliferation and survival. Mutations in KIT gene or overexpression of CD117 drive neoplastic transformation. Constitutive activation of CD117 signaling is central to GIST pathogenesis and represents therapeutic target
Follow-up Tests
- Complementary Immunohistochemical Markers: • DOG1 (Discovered on GIST) - highly specific for GISTs, often more specific than CD117 • CD34 - expressed in approximately 60-70% of GISTs, assists in GIST confirmation • Smooth muscle actin (SMA) - helps differentiate from smooth muscle neoplasms • Desmin - another marker for smooth muscle tumors • S100 protein - evaluates for nerve sheath origin
- Molecular Testing: • KIT gene mutation analysis - identifies specific mutations associated with GIST • PDGFRA gene mutation testing - detects alternative GIST mutations • Sequencing may guide targeted therapy decisions
- Imaging Studies if GIST Confirmed: • CT scan of abdomen and pelvis - assess tumor size, location, and metastatic disease • Endoscopic ultrasound (EUS) - for upper GI tumors • PET-CT - staging and detection of metastases
- Additional Studies for Mast Cell Disorders: • Tryptase level - serum markers for mastocytosis • Flow cytometry - assesses abnormal mast cell populations • Bone marrow biopsy - may be warranted for systemic mastocytosis
- Monitoring and Surveillance: • Post-surgical follow-up imaging every 3-6 months for high-risk GISTs • Regular clinical assessment for metastatic disease • Monitoring for treatment response in patients on tyrosine kinase inhibitor therapy • Long-term surveillance as GISTs can recur years after initial resection
- Risk Stratification: • Assessment of mitotic rate and tumor size guides prognosis classification • Combination of pathologic features determines follow-up intensity • Genetic testing results influence surveillance recommendations
Fasting Required?
- Fasting Not Required: No fasting is necessary for this test as it is performed on tissue specimens (biopsy or surgical samples) rather than blood specimens
- Specimen Collection Requirements: • Test is performed on formalin-fixed, paraffin-embedded (FFPE) tissue samples • Tissue must be properly fixed in 10% neutral buffered formalin immediately after collection • Fixation time: typically 6-24 hours depending on tissue thickness • Optimal fixation is critical for IHC staining quality
- Preparation Instructions for Tissue Biopsy: • Local anesthesia is typically used for biopsy procedures • Patients may have mild discomfort or pressure during tissue collection • Appropriate NPO status depends on biopsy method (endoscopic biopsies may require NPO 6-8 hours) • For surgical specimens, standard surgical preparation applies based on type of surgery
- Medications: No medications need to be avoided specifically for this test. However, medications affecting coagulation (aspirin, warfarin, NSAIDs) may need adjustment if tissue sampling requires biopsy procedure - consult with physician
- Post-Procedure Instructions (if biopsy required): • Follow post-biopsy care instructions provided by endoscopist or surgeon • Observe for signs of bleeding or infection • Resume normal diet unless otherwise instructed • Contact physician if unusual symptoms develop

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