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

NCT05530759 | Recruiting DMC

• 2 other identifiers: 21-008623NCI-2022-03313
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Deoxyribonucleic acid (DNA) alterations

  identify molecular targets for which therapeutic drugs may exist

  Through study completion; up to five years

• Proteomic changes in both biopsies and resected tumors

  identify molecular targets for which therapeutic drugs may exist

  Through study completion; up to five years

Study Arms (1)

Ancillary-Correlative (biospecimen collection)

Patients undergo collection of blood and buccal samples before or after 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.

Procedure: Biopsy Specimen; Procedure: Biospecimen Collection; Other: Medical Chart Review

Interventions

Biopsy Specimen PROCEDURE

Undergo collection of tissue samples

Also known as: Biopsy Sample

Ancillary-Correlative (biospecimen collection)

Biospecimen Collection PROCEDURE

Undergo collection of blood and buccal swab samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Ancillary-Correlative (biospecimen collection)

Medical Chart Review OTHER

Review of medical record

Also known as: Chart Review

Ancillary-Correlative (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified internally through provider referrals most commonly from providers in Medical Oncology.

You may qualify if:

• Patients (or the legally authorized representative/guardian signing on behalf of the participant) must understand and provide written informed consent prior to initiation of any study-specific procedures
• \>= 18 years of age
• Patients must have a diagnosis of confirmed malignancy
• Patient is a good medical candidate for a standard of care biopsy or surgical procedure to obtain tissue or has archival tissue available for analysis

You may not qualify if:

• Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
• Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use
• Biopsy must not be considered to be more than minimal risk to the patient. Contraindications to percutaneous biopsy:
• Significant coagulopathy that cannot be adequately corrected
• Severely compromised cardiopulmonary function or hemodynamic instability
• Lack of a safe pathway to the lesion
• Inability of the patient to cooperate with, or to be positioned for, the procedure

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue and buccal samples

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Aaron S. Mansfield, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 7, 2022
• Study Start: June 29, 2022
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

US (1)