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

June 5, 2026 updated by: Mayo Clinic

Integrated Genomics and Patient-Derived Cancer Models

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Aaron S. Mansfield, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Undergo collection of tissue samples
Other Names:
  • Biopsy Sample
Procedure: Biospecimen Collection
Undergo collection of blood and buccal swab samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Medical Chart Review
Review of medical record
Other Names:
  • Chart Review
Procedure: Archived Biospecimen Collection
Undergo collection of archived tissue and blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Biospecimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deoxyribonucleic acid (DNA) alterations
Time Frame: Through study completion; up to five years
identify molecular targets for which therapeutic drugs may exist
Through study completion; up to five years
Proteomic changes in both biopsies and resected tumors
Time Frame: Through study completion; up to five years
identify molecular targets for which therapeutic drugs may exist
Through study completion; up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Aaron S. Mansfield, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Estimated)

April 30, 2031

Study Completion (Estimated)

April 30, 2031

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-008623
  • NCI-2022-03313 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe