A Study of Application of Clonal Analysis to Study Flow Sorted Clinical Samples from Patients with Advanced Solid Tumors
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 12-004713
Sponsor Protocol Number: 12-004713
About this study
This study is being done so researchers can study the genetics of your tumor to better understand how the tumor grows and spreads and collect a blood sample to analyze the genetic material (DNA).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Suspected or cytological/histologically confirmed advanced solid tumors undergoing standard of care image guided biopsy or surgical procedure
- Age > 18 years
- Willingness to provide tissue, blood samples for genomic analyses
- International Normalized Ration (INR) < 1.5 x ULN (within 14 days prior to registration)
- PTT < 1.5 x ULN (within 14 days prior to registration)
- Eastern Cooperative Group (ECOG) performance status (PS) of 0-2 (Appendix I)
- Platelet count >100,000 /μL (within 14 days prior to registration)
- Ability to provide informed consent
- Patients who have frozen tumor tissue/germline DNA available and who agreed to allow for their tissue to be utilized for other studies/shared with other institutions at the time of consent (including IRB#2130-00, P.I.: Barbara Pockaj, M.D.).
Exclusion Criteria:
- In the opinion of the investigator, unfit or unsuitable to undergo standard of care image guided biopsy procedure
- Women of childbearing potential MUST NOT be pregnant or breast feeding.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mitesh Borad, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available