Clinical trial · Observational
Evaluating the Predictive Capability of Transcriptomic Profiling for Identifying the Primary Site of Metastatic Tumors
Evaluative Study on Predicting the Primary Site of Metastatic Tumors Using Transcriptomic Profiling for Tumor Tissue Origin Identification
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will enroll patients with metastatic malignancies. Tumor samples (fresh or formalin-fixed paraffin-embedded tissue specimens) will undergo RNA extraction and next-generation sequencing (RNA-seq). Once the raw data is obtained, the system will analyze the transcriptomic feature values (cancer-specific RNA transcripts and tissue-specific RNA transcripts) expressed in the tumor tissue samples to further predict tissue origin using a machine learning model. The output includes probabilities and confidence intervals for tissue origin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CUP | Malignant Neoplasm of Unknown Primary | ALIAS | 0.90 |
| Malignant Tumor With Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The accuracy of the transcriptomic profiling for tumor tissue origin identification in predicting the primary site of metastatic tumors
- timeFrame
- through study completion, an average of 1 year
- description
- Overall accuracy of the tumor tissue origin tracing transcriptome test for predicting the primary site of metastatic tumors (number of correct predictions/total evaluable cases); Specificity \[true negatives/(true negatives + false positives)\]; Sensitivity \[true positives/(true positives + false negatives)\].
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria 1. Clinically confirmed diagnosis of malignant tumor with metastasis; 2. Metastatic lesions confirmed as malignant by histopathology; 3. Sufficient surgical resection or biopsy specimens retained to meet the requirements for next-generation sequencing; 4. The participant (or their legal representative/guardian) has signed the informed consent form, confirming full understanding of the study's purpose and procedures, and voluntarily agrees to participate. Exclusion Criteria: 1\. The investigator deems the patient unable to provide informed consent.
References
Publications (3)
- BACKGROUNDShi Q, Li X, Liu Y, Chen Z, He X. FLIBase: a comprehensive repository of full-length isoforms across human cancers and tissues. Nucleic Acids Res. 2024 Jan 5;52(D1):D124-D133. doi: 10.1093/nar/gkad745. PMID 37697439
- BACKGROUNDShi Q, Liu T, Hu W, Chen Z, He X, Li S. SRTdb: an omnibus for human tissue and cancer-specific RNA transcripts. Biomark Res. 2022 Apr 26;10(1):27. doi: 10.1186/s40364-022-00377-1. PMID 35473935
- BACKGROUNDLee MS, Sanoff HK. Cancer of unknown primary. BMJ. 2020 Dec 7;371:m4050. doi: 10.1136/bmj.m4050. PMID 33288500