Characteristic Analysis of Retinopathy Associated With Hi... | NCT02702973

Studies
Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy

NCT02702973

Sponsor

The First Hospital of Jilin University

Status

Unknown status

Last Update Posted

Mar 9, 2016Estimated

Enrollment

1Estimated

Phase

Not provided

Conditions

Retinopathy

Interventions

Observe the fundus characteristics after therapy.

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Feb 18, 2016

First Submission Date that Met QC Criteria

Mar 8, 2016

First Posted Date

Mar 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2016

Last Update Posted Date

Mar 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observe the fundus characteristics		Observe the fundus characteristics after high doses of interferonα-2b therapy in patients with melanomas of the skin.	Other: Observe the fundus characteristics after therapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observe the fundus characteristics after therapy.	Other		Observe the fundus characteristics

Measure	Description	Time Frame
Change of ocular fundus after high doses of interferon α-2b therapy at the 1st week.		the 1st week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Eighteen patients with melanomas of the skin whose tumors have been resected completely were collected

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Di Wu, doctor	Contact	+86-139-4488-8991		wudi888991@163.com
Jie Shi Lan, doctor	Contact	+86-138-4312-8805

Facility	Status	City	State	ZIP	Country	Contacts
Jilin University,No.1 Hospital	Recruiting	Changchun	Jilin	130000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34524220	Derived	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.