Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy
CARI2b
1 other identifier
observational
1
1 country
1
Brief Summary
The high doses of interferon α-2b therapy in patients with melanomas of the skin may induced retinopathy, especially in the patients with hypertension or diabetes, so these patients should be followed up after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 9, 2016
February 1, 2016
1.8 years
February 18, 2016
March 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of ocular fundus after high doses of interferon α-2b therapy at the 1st week.
the 1st week
Study Arms (1)
Observe the fundus characteristics
Observe the fundus characteristics after high doses of interferonα-2b therapy in patients with melanomas of the skin.
Interventions
Eligibility Criteria
Eighteen patients with melanomas of the skin whose tumors have been resected completely were collected
You may qualify if:
- Men and women, at least 18 years of age.
- ECOG performance status 0 or 1.
- Patients must have histologically confirmed stage IB to stage III primary melanoma of cutaneous origin (AJCC 7th edition classification).
- Must complete all primary therapy (wide excision with or without lymphadenectomy).
You may not qualify if:
- Mucous membrane or ocular melanoma.
- Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening).
- Patients with retinopathy on baseline fundoscopic examination at the start of interferon therapy.
- History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix).
- Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
- Patients who have a history of depression or other psychiatric diseases requiring hospitalisation.
- History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes),
- Unwilling or unable to comply with the requirements of the protocol for the duration of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jilin University,No.1 Hospital
Changchun, Jilin, 130000, China
Related Publications (1)
Lan S, Cui Z, Yin Q, Liu Z, Liang L, He H, Liu H, Guo Z, Yu Y, Wu D. Prospective study of clinical characteristics of melanoma patients with retinopathy caused by a high-dose interferon alpha-2b. Melanoma Res. 2021 Dec 1;31(6):550-554. doi: 10.1097/CMR.0000000000000769.
PMID: 34524220DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2016
First Posted
March 9, 2016
Study Start
December 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
March 9, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will share