Defining the Immunologic Profile of Sentinel Lymph Nodes and Identifying the Mechanisms Responsible for Immunosuppression
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
- Rochester, Minnesota: 10-000806
- Jacksonville, Florida: 10-000806
Sponsor Protocol Number: 10-000806
About this study
The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.
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:
The patients on this protocol will have been evaluated and treated for their cancer using the standard of care as discussed by the treating physician.
Cohort 1:
- Histologically confirmed primary cutaneous melanoma
- Patients with clinically stage I-II melanoma
- 18 years of age and older
- Breslow depth of invasion > 0.75 mm
- Patients who are undergoing a sentinel lymph node (SLN) biopsy as part of their surgical intervention as determined by their treating surgeon.
- Patients on the following immunosuppressive medications can be considered for accrual (but use of these medications will be documented by the study coordinator if used within 6 weeks of surgery)
- Aspirin (daily)
- Ibuprofen
- NSAIDs
- Low dose steroids
- Consent to pre-operative 10cc peripheral blood draw
Cohort 2:
- Women 18 years of age or older
- Patients who have chosen to undergo a prophylactic mastectomy.
- Patients on the following immunosuppressive medications can be considered for accrual (but use of these medications will be documented by the study coordinator if used within 6 weeks of surgery)
- Aspirin (daily)
- Ibuprofen
- NSAIDs
- Low dose steroids
Exclusion Criteria:
Cohort 1:
- Biopsy proven regional lymph node involvement.
- Immunosuppressive medications within the past 6 weeks including:
- High dose steroids
- TNF-inhibitors
- Methotrexate
- IL-1Ra antagonist
- Women who are pregnant or nursing
- Elect not to provide peripheral blood draw
Cohort 2:
- History of ipsilateral breast cancer
- Contralateral inflammatory breast cancer
- Incidental invasive breast cancer identified in the ipsilateral breast during pathologic review of the mastectomy specimen.
- No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen
- Neoadjuvant chemotherapy within the past year
- Immunosuppressive mediations within the past 6 weeks including:
- High dose steroids
- TNF-inhibitors
- Methotrexate
- IL-1Ra antagonist
- Women who are pregnant or nursing
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 |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Svetomir Markovic, M.D., Ph.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator James Jakub, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available