Stage III MelanomaITMTNCT02794636
Interferon Toxicities in Melanoma Treatment
An observational study of Stage III Melanoma, run by Bristol-Myers Squibb.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Melanoma
- How many people
- 436 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Health plan enrollees whose data are reflected in the Truven Health MarketScan Commercial and Medicare Supplemental database. This database captures clinical utilization, expenditures and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Analysis of the Clinical and Economic Impact of Adverse Events and Medication-related Toxicities Associated With Interferon (IFN) Treatment for Patients With Stage III Melanoma
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.
- Conditions
- Stage III Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy
Measured: 180 days prior to the index date
Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy
Measured: 180 days after the index date
Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy
Measured: 180 days prior to the index date
Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy
Measured: 180 days after the index date
Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy
Measured: 180 days prior to the index date
Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy
Measured: 180 days after the index date
Secondary outcomes (6)
Pre-IFN treatment period Health care costs related to depression
Measured: 180 days prior to the index date
Post-IFN treatment period Health care costs related to depression
Measured: 180 days after the index date
Pre-IFN treatment period Health care costs related to fatigue
Measured: 180 days prior to the index date
Post-IFN treatment period Health care costs related to fatigue
Measured: 180 days after the index date
Pre-IFN treatment period Health care costs related to myalgia
Measured: 180 days prior to the index date
Post-IFN treatment period Health care costs related to myalgia
Measured: 180 days after the index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794636
- Sponsor's protocol ID
- CA184-404
- Acronym
- ITMT
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Clinical and Economic Impact of Adverse Events and Medication-related Toxicities Associated With Interferon (IFN) Treatment for Patients With Stage III Melanoma
- ClinicalTrials.gov ID
- NCT02794636
- Acronym / sponsor ID
- ITMT / CA184-404
- Conditions
- Stage III Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Jun 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Health plan enrollees whose data are reflected in the Truven Health MarketScan Commercial and Medicare Supplemental database. This database captures clinical utilization, expenditures and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy
Time frame: 180 days prior to the index date
Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy
Time frame: 180 days after the index date
Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy
Time frame: 180 days prior to the index date
Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy
Time frame: 180 days after the index date
Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy
Time frame: 180 days prior to the index date
Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy
Time frame: 180 days after the index date
6 secondary outcomes
Pre-IFN treatment period Health care costs related to depression
Time frame: 180 days prior to the index date
Post-IFN treatment period Health care costs related to depression
Time frame: 180 days after the index date
Pre-IFN treatment period Health care costs related to fatigue
Time frame: 180 days prior to the index date
Post-IFN treatment period Health care costs related to fatigue
Time frame: 180 days after the index date
Pre-IFN treatment period Health care costs related to myalgia
Time frame: 180 days prior to the index date
Post-IFN treatment period Health care costs related to myalgia
Time frame: 180 days after the index date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Melanoma, run by Bristol-Myers Squibb.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy (time frame: 180 days prior to the index date). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2016.