A Study to Describe Patterns of Treatment, Demographics, Clinical Characteristics, and Overall Survival in Patients with Unresectable or Metastatic Melanoma
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: 16-000438
NCT ID: NCT02780089
Sponsor Protocol Number: CA209357
About this study
The purpose of this study is to describe the demographics, clinical characteristics and different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.
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.
Closed to enrollment
Inclusion Criteria
- Prospective cohort patients
- Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)
- Has diagnosis of stage III (unresectable) or stage IV (metastatic) melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)
- Age ≥ 18 years at time of entry into study
- Must be actively receiving or scheduled to receive systemic treatment of any line, eg, first, second, third line [including investigational drugs]
- For patients initiating new treatment, treatment must be started within 28 days after signing informed consent
- For patients currently receiving treatment, patients must enroll within the first 21 days of starting new treatment
- Retrospective cohort patients
- Has diagnosis of confirmed unresectable stage III or stage IV metastatic melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)
- Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis
- Initiated therapy for unresectable or metastatic melanoma within 4 years prior to approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)
- March 25, 2007 - March 24, 2011
- One year of follow-up data is required from date of therapy initiation
- If patient passed away within the one year of follow-up they are still eligible and the date of death will be collected
- If retrospective patients have at least one year of follow-up data and are then treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted therapy, these patients will be analyzed separately
Exclusion Criteria
- Prospective patients
- Are participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded
- Started new treatment > 21 days prior to enrollment
- Enrolled in study but did not initiate treatment before 28 days
- Have current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that require additional systemic therapy
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 Lisa Kottschade, APRN, C.N.P. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available