Recruiting

Genetic & Proteomic Analysis

Sponsor:

Mayo Clinic

Code:

NCT05530759

Conditions

Hematopoietic and Lymphoid System Neoplasm

Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Specimen

Biospecimen Collection

Archived Biospecimen Collection

Medical Chart Review

Study Details

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

Study ID

NCT05530759

Start date

Jun 29, 2022

Status verified date

Jun, 2026

Completion date

Apr 30, 2031

Anticipated

Primary completion date

Apr 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biopsy Specimen

Undergo collection of tissue samples

Biospecimen Collection

Undergo collection of blood and buccal swab samples

Archived Biospecimen Collection

Undergo collection of archived tissue and blood samples

Medical Chart Review

Review of medical record

Primary outcome measure

  • Deoxyribonucleic acid (DNA) alterations [ Time Frame: Through study completion; up to five years ]
  • Proteomic changes in both biopsies and resected tumors [ Time Frame: Through study completion; up to five years ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Aaron S. Mansfield, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-09.