NCT04751396 Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
| NCT ID | NCT04751396 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Ankylosing Spondylitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2022-04-20 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2022-04-20 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of melanoma * Diagnosis of pre-existing autoimmune disease * Inflammatory bowel disease * Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist * For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically * Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists) * Rheumatoid arthritis * Diagnosis of rheumatoid arthritis by a rheumatologist * Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy * Systemic lupus erythematosus * Diagnosis of systemic lupus erythematosus by a rheumatologist * Psoriasis * Diagnosis of psoriasis by a dermatologist * Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies * Spondyloarthropathies * Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis/spondylitis by a rheumatologist * Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy * Age of 18 years or older * Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor * E-mail access and computer with Internet access or telephone * Ability to communicate in English or Spanish * CLINICIAN * Prescribed immune checkpoint inhibitors * Are providing care for patients with melanoma * In the clinics at MD Anderson
Contact & Investigator
Angeles Lopez-Olivo
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04751396 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ankylosing Spondylitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04751396 currently recruiting?
Yes, NCT04751396 is actively recruiting participants. Contact the research team at amlopezo@mdanderson.org for enrollment information.
Where is the NCT04751396 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04751396 clinical trial?
NCT04751396 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Angeles Lopez-Olivo at M.D. Anderson Cancer Center. The trial plans to enroll 125 participants.