RetinopathyCARI2bNCT02702973
Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy
An observational study of Retinopathy, run by The First Hospital of Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy
- What is being tested?
- Observe the fundus characteristics after therapy.
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Oct 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eighteen patients with melanomas of the skin whose tumors have been resected completely were collected
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jie Shi Lan, doctor contact
China1 site, 1 recruiting
- Recruiting
Jilin University,No.1 Hospital
Changchun, Jilin, 130000
Di Wu, doctor, +86-139-4488-8991, wudi888991@163.com
About this study
Official title: Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy in Patients With Melanomas of the Skin
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.
Read the detailed description
Patients with melanomas of the skin whose tumors have been resected completely were collected. The detailed ocular examinations including intraocular pressure, slit lamp microscope, indirect ophthalmoscope and color fundus photography were done before the induction therapy, 2 weeks after the induction therapy, after the whole course of induction therapy and each month in the maintenance treatment period. Fundus examinations were carried out by experienced ocular fundus doctors and the retinopathy characteristics were recorded.
- Conditions
- Retinopathy
- Being tested
- Observe the fundus characteristics after therapy.
- Keywords
- Characteristic analysis
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observe the fundus characteristics after therapy.Other
| Study group | Role | What they receive |
|---|---|---|
| Observe the fundus characteristics | Observe the fundus characteristics after high doses of interferonα-2b therapy in patients with melanomas of the skin. Receives: Other: Observe the fundus characteristics after therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ocular fundus after high doses of interferon α-2b therapy at the 1st week.
Measured: the 1st week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetinopathyStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Enrolment
- 1 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702973
- Sponsor's protocol ID
- 2016WD2M1
- Acronym
- CARI2b
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 34524220
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy in Patients With Melanomas of the Skin
- ClinicalTrials.gov ID
- NCT02702973
- Acronym / sponsor ID
- CARI2b / 2016WD2M1
- Conditions
- Retinopathy
- Keywords
- Characteristic analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with melanomas of the skin whose tumors have been resected completely were collected. The detailed ocular examinations including intraocular pressure, slit lamp microscope, indirect ophthalmoscope and color fundus photography were done before the induction therapy, 2 weeks after the induction therapy, after the whole course of induction therapy and each month in the maintenance treatment period. Fundus examinations were carried out by experienced ocular fundus doctors and the retinopathy characteristics were recorded.
Study design
- Observational model
- Case crossover
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observe the fundus characteristics | – | Other: Observe the fundus characteristics after therapy.Observe the fundus characteristics after high doses of interferonα-2b therapy in patients with melanomas of the skin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eighteen patients with melanomas of the skin whose tumors have been resected completely were collected
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observe the fundus characteristics after therapy. | Other | Observe the fundus characteristics |
Primary outcome
Change of ocular fundus after high doses of interferon α-2b therapy at the 1st week.
Time frame: the 1st week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Derived from this study: PubMed 34524220Lan 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Shi Lan, doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Wu, doctor (+86-139-4488-8991, wudi888991@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of ocular fundus after high doses of interferon α-2b therapy at the 1st week. (time frame: the 1st week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.