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

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ClinicalTrials.gov Identifier: NCT05530759
Recruitment Status : Recruiting
First Posted : September 7, 2022
Last Update Posted : September 8, 2023
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment
Hematopoietic and Lymphoid System Neoplasm Metastatic Malignant Solid Neoplasm Procedure: Biopsy Specimen Procedure: Biospecimen Collection Other: Medical Chart Review

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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Integrated Genomics and Patient-Derived Cancer Models
Actual Study Start Date : June 29, 2022
Estimated Primary Completion Date : April 7, 2027
Estimated Study Completion Date : April 7, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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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 Name: Biopsy Sample

Procedure: Biospecimen Collection
Undergo collection of blood and buccal swab samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Procedure: Biospecimen Collection
Undergo collection of archived tissue and blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Other: Medical Chart Review
Review of medical record
Other Name: Chart Review


Outcome Measures
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Primary Outcome Measures :
  1. Deoxyribonucleic acid (DNA) alterations [ Time Frame: Through study completion; up to five years ]
    identify molecular targets for which therapeutic drugs may exist

  2. 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


Biospecimen Retention:   Samples With DNA
Blood, tissue and buccal samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05530759


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Aaron S. Mansfield, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Aaron S. Mansfield, M.D. Mayo Clinic in Rochester
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT05530759    
Other Study ID Numbers: 21-008623
NCI-2022-03313 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: September 7, 2022    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: September 2023

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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
Additional relevant MeSH terms:
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Neoplasms