NCT04510766

Tumor Molecular Profiling in Early Phase Clinical Trials

Molecular Characterization of Solid Tumors and Lymphomas to Optimize the Drug Development Process and Patients Enrollment in Early Phase Clinical Trials

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Oncology Institute of Southern Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.

Detailed description

Single center, two-parts pilot, prospective study to assess the role of molecular tumor profiling in supporting patient enrollment in early phase clinical trials. Part A: patients with solid tumors or lymphomas (n=40) who are potential candidates for early phase clinical trials will be offered to have their more recent archival tumor tissue analyzed for the presence of somatic genomic alterations with the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 platform. Part B: patients who have been enrolled in early phase clinical trials (estimated number: 16-18) will have their archival tumor tissue assessed with HTG EdgeSeq Oncology Biomarker Panel Assay for RNA-Seq to explore gene expression signatures and blood collected and stored to create a repository of samples (¨liquid biopsy¨) for future research with the aim to investigate the mutational profile of ctDNA at baseline and the acquisition of new mutations at the time of disease progression as a consequence of treatment exposure.

Conditions

• Advanced Solid Tumor
• Lymphoma

Timeline

• Start date: 2020-10-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-08-12
• Last updated: 2025-11-18

Locations

1 site across 1 country: Switzerland