Clinical trial NCT05530759: Examining Blood and Tissue Samples to Identify Diagnostic Markers in Patients With Metastatic Cancer Undergoing Tumor Removal
Official title: Integrated Genomics and Patient-Derived Cancer Models
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphoid System Neoplasm
Metastatic Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified internally through provider referrals most commonly from providers in Medical Oncology.

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.

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.

Eligibility 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

Primary outcomes:
measure: Deoxyribonucleic acid (DNA) alterations
timeFrame: Through study completion; up to five years
measure: Proteomic changes in both biopsies and resected tumors
timeFrame: Through study completion; up to five years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Aaron S. Mansfield, M.D.
role: PRINCIPAL_INVESTIGATOR
References: