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Trial Title:
Examining Blood and Tissue Samples to Identify Diagnostic Markers in Patients With Metastatic Cancer Undergoing Tumor Removal
NCT ID:
NCT05530759
Condition:
Hematopoietic and Lymphoid System Neoplasm
Metastatic Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy Specimen
Description:
Undergo collection of tissue samples
Arm group label:
Ancillary-Correlative (biospecimen collection)
Other name:
Biopsy Sample
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood and buccal swab samples
Arm group label:
Ancillary-Correlative (biospecimen collection)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of archived tissue and blood samples
Arm group label:
Ancillary-Correlative (biospecimen collection)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Medical Chart Review
Description:
Review of medical record
Arm group label:
Ancillary-Correlative (biospecimen collection)
Other name:
Chart Review
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.
Criteria for eligibility:
Study pop:
Participants will be identified internally through provider referrals most commonly from
providers in Medical Oncology.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Aaron S. Mansfield, M.D.
Email:
Principal Investigator
Start date:
June 29, 2022
Completion date:
April 7, 2028
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05530759
https://www.mayo.edu/research/clinical-trials
