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NCT04751396Recruiting

Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors

Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors: Acceptability and Usability With Patients and Providers

Source: ClinicalTrials.gov · Last updated 20 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
125 (estimated)
First submitted
8 Feb 2021
Start date
20 Apr 2022
Primary completion date
2 Feb 2027
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT04751396

What you commit to

  • Study type: Observational
  • Planned participants: 125
  • From 20 Apr 2022 to the primary completion date, 2 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.