Clinical trial · Observational
A Multicenter Cancer Biospecimen Collection Study
Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
NCT04510129CI-TRIAL-00087043recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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 collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Small-cell Lung Cancer |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OncoPrism™ assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (11)
- label
- head and neck squamous cell carcinoma (HNSCC)
- interventionNames
- Diagnostic Test: OncoPrism™ assay
- label
- non-small-cell lung cancer (NSCLC)
- interventionNames
- Diagnostic Test: OncoPrism™ assay
- label
- small cell lung cancer (SCLC)
- interventionNames
- Diagnostic Test: OncoPrism™ assay
- label
- urothelial carcinoma (UCC)
- interventionNames
- Diagnostic Test: OncoPrism™ assay
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject must have a disease of interest. Specifically, subject must have one of: 1. head and neck squamous cell carcinoma (HNSCC) 2. non-small-cell lung cancer (NSCLC) 3. small cell lung cancer (SCLC) 4. urothelial carcinoma (UCC) 5. gastric or gastroesophageal junction adenocarcinoma 6. cervical cancer 7. esophageal squamous cell carcinoma (ESCC) 8. triple-negative breast cancer (TNBC) 9. hepatocellular carcinoma (HCC) 10. renal cell carcinoma (RCC) 11. colorectal cancer (CRC) 2. Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer. 3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy. 4. Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy. 5. Willing to provide electronic informed consent per IRB-approved protocol. 6. Able to speak, read, and comprehend English fluently. 7. Subject is 18 years of age or older. 8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study. Exclusion Criteria: 1. Inability or unwillingness to provide informed consent. 2. Subject who does/did not have one of the cancers listed above (other histologies). 3. Subject has already participated in this trial.
References
Publications (1)
- DERIVEDFlanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study. J Immunother Cancer. 2024 Nov 3;12(11):e009573. doi: 10.1136/jitc-2024-009573. PMID 39489541