Examining Blood and Tissue Samples to Identify Diagnostic Markers in Patients With Metastatic Cancer Undergoing Tumor Removal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Significant coagulopathy that cannot be adequately corrected
Severely compromised cardiopulmonary function or hemodynamic instability
Trial population
Participants will be identified internally through provider referrals most commonly from providers in Medical Oncology.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Biopsy Specimen
Procedure/SurgeryUndergo collection of tissue samples
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood and buccal swab samples
Archived Biospecimen Collection
Procedure/SurgeryUndergo collection of archived tissue and blood samples
Medical Chart Review
Other interventionReview of medical record
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Ancillary-Correlative (biospecimen collection)4 interventions
Trial outcomes
Primary outcomes
1
Deoxyribonucleic acid (DNA) alterations
identify molecular targets for which therapeutic drugs may exist
Time frame
Through study completion; up to five years2
Proteomic changes in both biopsies and resected tumors
identify molecular targets for which therapeutic drugs may exist
Time frame
Through study completion; up to five yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov