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 : January 6, 2023
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|Condition or disease||Intervention/treatment|
|Hematopoietic and Lymphoid System Neoplasm Metastatic Malignant Solid Neoplasm||Procedure: Biopsy Specimen Procedure: Biospecimen Collection Other: Medical Chart Review|
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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
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
Procedure: Biospecimen Collection
Undergo collection of archived tissue and blood samples
Other: Medical Chart Review
Review of medical record
Other Name: Chart Review
- Deoxyribonucleic acid (DNA) alterations [ Time Frame: Through study completion; up to five years ]identify molecular targets for which therapeutic drugs may exist
- 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
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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|
- 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
- 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
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
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trial Referral Office 855-776-0015 email@example.com|
|Principal Investigator: Aaron S. Mansfield, M.D.|
|Principal Investigator:||Aaron S Mansfield||Mayo Clinic in Rochester|
|Responsible Party:||Mayo Clinic|
|Other Study ID Numbers:||
NCI-2022-03313 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
|First Posted:||September 7, 2022 Key Record Dates|
|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|