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

• ClinicalTrials.gov Identifier: NCT05530759
• Recruitment Status: Recruiting
• First Posted: September 7, 2022
• Last Update Posted: January 6, 2023
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Mayo Clinic

Study Description

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

• 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

Groups and Cohorts

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

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

• 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

Locations

United States, Minnesota

Mayo Clinic in Rochester; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Clinical Trial Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator: Aaron S. Mansfield, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Aaron S Mansfield; Mayo Clinic in Rochester

More Information

• 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
• Last Update Posted: January 6, 2023
• Last Verified: January 2023

• 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:

Neoplasms