Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT05530759
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining Blood and Tissue Samples to Identify Diagnostic Markers in Patients With Metastatic Cancer Undergoing Tumor Removal
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Integrated Genomics and Patient-Derived Cancer Models
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-03313 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |