Melanoma (Skin)NCT00897520
Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy
An observational study of Melanoma (Skin), run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment. PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- recombinant interferon alfa, proteomic profiling and immunoenzyme technique
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2008to 24 Jan 2010
- 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Samples submitted for research from patients participating in E1694
DISEASE CHARACTERISTICS:
- Diagnosis of high-risk melanoma
- Receiving interferon alfa-2b therapy in arm II of clinical trial E-1694
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment.
PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.
Read the detailed description
OBJECTIVES:
- To screen serum specimens using a high throughput protein profiling platform that tests for the highest number of known biomarkers (detectable by antibodies) that could be predictors of response to interferon treatment, autoimmunity, and disease outcome in patients with high-risk melanoma undergoing high-dose interferon (IFNa2b) therapy .
- To compare soluble factors across all patients at each time point (baseline and during therapy).
- To compare pre-therapy vs post-therapy serum samples from these patients.
- To assess the kinetics of soluble factors' appearance, persistence, and disappearance during the 12 months of therapy.
- To assess whether the amount of specific soluble factors in the pre-therapy sample is predictive of response independent of therapy.
- To correlate statistically significant factors with S100 and autoimmunity in these patients.
- To confirm the data obtained with the Luminex technology.
OUTLINE: Patients are stratified according to survival (< 2 years vs > 5 years).
Blood samples collected from patients enrolled in E-1694 are analyzed using high throughput protein profiling by ELISA to compare changes in levels of putative biomarkers of interferon alfa-2b, including cytokines and paired receptors, chemokines, cell adhesion molecules, metalloproteinases, angiogenic markers, growth factors, soluble receptors, signal transduction molecules, hormones, and other biomarkers of disease and dysregulated immune processes, at baseline and during therapy.
- Conditions
- Melanoma (Skin)
- Being tested
- recombinant interferon alfa, proteomic profiling, immunoenzyme technique, laboratory biomarker analysis
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
proteomic profilingGenetic
immunoenzyme techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sample screening via high throughput protein profiling in patients undergoing therapy
Measured: 1 month
Comparison of soluble factors
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start14 Jan 2008
- Primary completion24 Jan 2010
- Study completion24 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Monica Panelli, PhD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897520
- Sponsor's protocol ID
- CDR0000585297
- Other IDs
- ECOG-E1694T1
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)
- ClinicalTrials.gov ID
- NCT00897520
- Acronym / sponsor ID
- CDR0000585297
- Conditions
- Melanoma (Skin)
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jan 2008 (actual)
- Primary completion
- 24 Jan 2010 (actual)
- Study completion
- 24 Jan 2010 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment.
PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.
Detailed description
OBJECTIVES:
- To screen serum specimens using a high throughput protein profiling platform that tests for the highest number of known biomarkers (detectable by antibodies) that could be predictors of response to interferon treatment, autoimmunity, and disease outcome in patients with high-risk melanoma undergoing high-dose interferon (IFNa2b) therapy .
- To compare soluble factors across all patients at each time point (baseline and during therapy).
- To compare pre-therapy vs post-therapy serum samples from these patients.
- To assess the kinetics of soluble factors' appearance, persistence, and disappearance during the 12 months of therapy.
- To assess whether the amount of specific soluble factors in the pre-therapy sample is predictive of response independent of therapy.
- To correlate statistically significant factors with S100 and autoimmunity in these patients.
- To confirm the data obtained with the Luminex technology.
OUTLINE: Patients are stratified according to survival (< 2 years vs > 5 years).
Blood samples collected from patients enrolled in E-1694 are analyzed using high throughput protein profiling by ELISA to compare changes in levels of putative biomarkers of interferon alfa-2b, including cytokines and paired receptors, chemokines, cell adhesion molecules, metalloproteinases, angiogenic markers, growth factors, soluble receptors, signal transduction molecules, hormones, and other biomarkers of disease and dysregulated immune processes, at baseline and during therapy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Samples submitted for research from patients participating in E1694
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 |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| proteomic profiling | Genetic | – |
| immunoenzyme technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Serum sample screening via high throughput protein profiling in patients undergoing therapy
Time frame: 1 month
Comparison of soluble factors
Time frame: 1 month
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 19 May 2017.
Related trials for Melanoma (Skin)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Monica Panelli, PhD study chair
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin), run by ECOG-ACRIN Cancer Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 May 2017. 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?
Serum sample screening via high throughput protein profiling in patients undergoing therapy (time frame: 1 month). The study lists 2 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 19 May 2017.