Interferon Toxicities in Melanoma Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

436 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and resource utilization before and after IFN initiation among patients with stage III melanoma in a real-world setting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma

NCT00085306

Stage IV Melanoma Recurrent Melanoma

COMPLETED PHASE2

High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

NCT00003641

Melanoma (Skin)

ACTIVE_NOT_RECRUITING PHASE3

Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

NCT01708941

Recurrent Melanoma Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 +2 more

ACTIVE_NOT_RECRUITING PHASE2

Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)

NCT00749684

Melanoma

COMPLETED

Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma

NCT00002767

Melanoma (Skin)

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stage III Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IFN Treatment

Adult (age ≥ 18 years) patients identified as having stage III melanoma and no other primary or secondary cancer who initiated treatment with IFN between 1/1/2007 and 12/31/2011. Patients are required to have continuous pharmaceutical benefit enrollment for 180 days before (pre-index) and after (post-index) IFN initiation and no evidence of treatment with systemic chemotherapy during the pre- or post-index period

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/2011. The date of the first observed claim will be defined as the index date
* Patients with a melanoma diagnosis based on two medical claims prior to the index date
* Patients with a procedure code for melanoma-related lymph node dissection before the index date
* Patients ≥ 18 years of age on or before the index date
* Patients with continuous benefit enrollment for at least 180 days before and after the index date

Exclusion Criteria

* Patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies)
* Patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer)
* Patients who received systemic chemotherapy during the pre- or post-index period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No