NCT05530759

Examining Blood and Tissue Samples to Identify Diagnostic Markers in Patients With Metastatic Cancer Undergoing Tumor Removal

Integrated Genomics and Patient-Derived Cancer Models

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study characterizes deoxyribonucleic acid (DNA) and proteomic (protein) changes in both biopsies and tumors removed during surgery of patients who have been diagnosed with aggressive/metastatic (that has spread to other places in the body) cancer in order to identify possible diagnostic markers and potential drugs for treating aggressive tumor types. Proteomic analyses include looking at the proteome, or all the proteins expressed, or made by DNA at a specific moment in time. Studying samples of blood, buccal (cheek), and tissue in the laboratory from patients undergoing surgical resection or biopsy may help doctors learn more about the changes that occur in the proteome, DNA alterations, and identify molecular biomarkers for which therapeutic drugs may exist. Studying the DNA in tumor tissue and in blood may also help researchers see if the tumor has important differences.

Detailed description

PRIMARY OBJECTIVES: I. To understand the pathogenesis, molecular mechanisms, and disease processes of malignancies. II. To examine the utility of integrated genomics for discovery of targets or pathways involved in tumor/malignancy progression of patients with malignancies. III. To observe for any evidence of anti-tumor activity from treatment if selected based on integrated genomics. IV. To create and offer opportunities for targeted individualized therapy based on the outcome of integrated genomics and micro-cancer modeling. V. To determine the outcome of patients with malignancies who received targeted individualized therapy. OUTLINE: This is an ancillary-correlative study. Patients undergo collection of blood and buccal samples before or after standard of care (SOC) biopsy or tumor resection. Patients undergo collection of tumor tissue at time of SOC biopsy or tumor resection. Patients' medical records are also reviewed. Patients' archived tissue or blood samples may also be collected.

Conditions

• Hematopoietic and Lymphoid System Neoplasm
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biopsy Specimen	Undergo collection of tissue samples
PROCEDURE	Biospecimen Collection	Undergo collection of blood and buccal swab samples
PROCEDURE	Biospecimen Collection	Undergo collection of archived tissue and blood samples
OTHER	Medical Chart Review	Review of medical record

Timeline

• Start date: 2022-06-29
• Primary completion: 2027-04-07
• Completion: 2028-04-07
• First posted: 2022-09-07
• Last updated: 2025-04-02

Locations

1 site across 1 country: United States