Trial reportThe American journal of surgical pathology2013
A multicenter study directly comparing the diagnostic accuracy of gene expression profiling and immunohistochemistry for primary site identification in metastatic tumors.
Trial report in The American journal of surgical pathology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 1 synthesis or guideline pooled it, 107 citations in OpenAlex.
- Evaluation of the Suitability of RNAscope as a Technique to Measure Gene Expression in Clinical Diagnostics: A Systematic Review.Molecular diagnosis & therapy · 2022Pooled it
- Integrating artificial intelligence into cancers of unknown primary diagnosis and treatment.iScience · 2026Review
- Immunohistochemistry (IHC) Versus Genomic Profiling in Cancer: Roles in Precision Medicine.Cureus · 2026Review
- Activating NRF2Cancer gene therapy · 2025Article
- Rethinking cancer of unknown primary: from diagnostic challenge to targeted treatment.Nature reviews. Clinical oncology · 2025Review
- Explainable AI Model Reveals Informative Mutational Signatures for Cancer-Type Classification.Cancers · 2025Article
- Advancements in Diagnostics and Therapeutics for Cancer of Unknown Primary in the Era of Precision Medicine.MedComm · 2025Review
- Case Report: Palliative chemotherapy with gemcitabine and carboplatin for carcinoma of unknown primary with metastasis in a cat.Frontiers in veterinary science · 2025Article
- Diagnostic Utility of a 90-Gene Expression Assay (Canhelp-Origin) for Patients with Metastatic Cancer with an Unclear or Unknown Diagnosis.Molecular diagnosis & therapy · 2025Article
- Tracing unknown tumor origins with a biological-pathway-based transformer model.Cell reports methods · 2024Article
- PD-L1 expression and microsatellite instability (MSI) in cancer of unknown primary site.International journal of clinical oncology · 2024Article
- KRT13 and UPK1B for differential diagnosis between metastatic lung carcinoma from oral squamous cell carcinoma and lung squamous cell carcinoma.Scientific reports · 2023Article
- Reparameterized multiobjective control of BCG immunotherapy.Scientific reports · 2023Article
- Validation of a Transcriptome-Based Assay for Classifying Cancers of Unknown Primary Origin.Molecular diagnosis & therapy · 2023Article
- Clinical outcomes of patients diagnosed with cancer of unknown primary or malignancy of undefined primary origin who were referred to a regional cancer center.International journal of clinical oncology · 2023Article
- From Biology to Diagnosis and Treatment: The Ariadne's Thread in Cancer of Unknown Primary.International journal of molecular sciences · 2023Review
- A comparison of DNA sequencing and gene expression profiling to assist tissue of origin diagnosis in cancer of unknown primary.The Journal of pathology · 2023Article
- Clinical validation of a 90-gene expression test for tumor tissue of origin diagnosis: a large-scale multicenter study of 1417 patients.Journal of translational medicine · 2022Article
- Molecular Pathology of Lung Cancer.Cold Spring Harbor perspectives in medicine · 2022Review
- Case Report: Successful Immunotherapy Improved the Prognosis of the Unfavorable Subset of Cancer of Unknown Primary.Frontiers in immunology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 1 country.
Funding
Abstract
Metastatic tumors with an uncertain primary site can be a difficult clinical problem. In tens of thousands of patients every year, no confident diagnosis is ever issued, making standard-of-care treatment impossible. Gene expression profiling (GEP) tests currently available to analyze these difficult-to-diagnose tumors have never been directly compared with the diagnostic standard of care, immunochemistry (IHC). This prospectively conducted, blinded, multicenter study compares the diagnostic accuracy of GEP with IHC in identifying the primary site of 157 formalin-fixed paraffin-embedded specimens from metastatic tumors with known primaries, representing the 15 tissues on the GEP test panel. Four pathologists rendered diagnoses by selecting from 84 stains in 2 rounds. GEP was performed using the Pathwork Tissue of Origin Test. Overall, GEP accurately identified 89% of specimens, compared with 83% accuracy using IHC (P=0.013). In the subset of 33 poorly differentiated and undifferentiated carcinomas, GEP accuracy exceeded that of IHC (91% to 71%, P=0.023). In specimens for which pathologists rendered their final diagnosis with a single round of stains, both IHC and GEP exceeded 90% accuracy. However, when the diagnosis required a second round, IHC significantly underperformed GEP (67% to 83%, P<0.001). GEP has been validated as accurate in diagnosing the primary site in metastatic tumors. The Pathwork Tissue of Origin Test used in this study was significantly more accurate than IHC when used to identify the primary site, with the most pronounced superiority observed in specimens that required a second round of stains and in poorly differentiated and undifferentiated metastatic carcinomas.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.