Clinical trial · Observational
Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's discretion to termination due to business decision.
Summary
Brief summary (as posted)
Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. The Strata Trial (STR-001-001) has been initiated by Strata Oncology to evaluate the clinical benefit of systematic comprehensive genomic profiling for participants with advanced cancer using real-world data and endpoints, while assessing the proportion of participants available for clinical trials and approved targeted therapies in advanced and/or aggressive cancers. The Strata Trial uses surplus, or leftover, tumor specimens for molecular profiling and does not require additional study-specific procedures.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Solid Tumor | Adult Solid Neoplasm | ALIAS | 0.90 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Time to Treatment Discontinuation (TTD)
- timeFrame
- 3 years
- description
- To evaluate TTD for participants who received an anticancer biomarker-guided therapy and, when available, as compared to prior TTD from prior anti-cancer therapy
- measure
- Time to Next Treatment (TTNT)
- timeFrame
- 3 years
- description
- To evaluate TTNT for participants who received and anticancer biomarker guided therapy and, when available, as compared to prior TTNT from prior anti-cancer therapy
Secondary outcomes (2)
- measure
- biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment
- timeFrame
- 3 years
- description
- To evaluate the proportion of participants with actionable genomic profiles that indicate a potential clinical benefit from standard of care biomarker-guided therapies or a clinical trial, and the proportion of participants who enroll on a clinical trial.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be ≥ 18 years of age. * Subjects must have histologically documented solid tumors (including lymphoma and multiple myeloma). * Specific criteria for individual tumor types are as follows: 1. Participants with gliomas are eligible at any stage of disease 2. Participants with pancreatic carcinoma are eligible at any stage of disease 3. Participants with rare tumors (i.e. cancer started in an unusual place in the body, it is unusual type and requires special treatment) are eligible at stages II-IV. 4. Participants with other tumor types must have recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer. 5. Participants with other tumor types must have recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer. * Must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.
References
Publications (1)
- DERIVEDTomlins SA, Hovelson DH, Suga JM, Anderson DM, Koh HA, Dees EC, McNulty B, Burkard ME, Guarino M, Khatri J, Safa MM, Matrana MR, Yang ES, Menter AR, Parsons BM, Slim JN, Thompson MA, Hwang L, Edenfield WJ, Nair S, Onitilo A, Siegel R, Miller A, Wassenaar T, Irvin WJ, Schulz W, Padmanabhan A, Harish V, Gonzalez A, Mansoor AH, Kellum A, Harms P, Drewery S, Falkner J, Fischer A, Hipp J, Kwiatkowski K, Lazo de la Vega L, Mitchell K, Reeder T, Siddiqui J, Vakil H, Johnson DB, Rhodes DR. Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples. JCO Precis Oncol. 2021 Aug 19;5:PO.20.00472. doi: 10.1200/PO.20.00472. eCollection 2021 Aug. PMID 34476329