Melanoma (Skin)NCT00897546
Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma
An observational study of Melanoma (Skin), run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- laboratory biomarker analysis
- How many people
- 1,716 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2007to 1 Jul 2008
- 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 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples submitted for research from patients participating in E1690 and E1694
DISEASE CHARACTERISTICS:
- Diagnosis of melanoma OR healthy volunteer (control)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Multiplex Analysis of Serum Biomarkers for Prediction Interferon Therapy Response in Melanoma Patients
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.
Read the detailed description
OBJECTIVES:
- Generate a comprehensive multiplexed array of melanoma-associated serological markers and validate it using serum samples from patients with melanoma and healthy control participants.
- Determine changes in the profile of serological markers induced by interferon-alfa 2b (IFN-α2b) therapy.
- Define panels of serological markers with prognostic and predictive power for IFN-α2b therapy responses in patients with melanoma.
OUTLINE: This is a multicenter study.
Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines, chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin, vasostatin, and vascular endothelial growth factor inhibitor.
PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- laboratory biomarker analysis
- Keywords
- recurrent melanoma, stage IV melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of a comprehensive multiplexed array of melanoma-associated serological markers
Generation of a comprehensive multiplexed array of melanoma-associated serological markers
Measured: 1 month
Secondary outcomes (2)
Changes in the profile of serological markers induced by interferon-alfa 2b therapy
Changes in the profile of serological markers induced by interferon-alfa 2b therapy
Measured: 1 month
Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response
Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response
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 start1 Jun 2007
- Primary completion1 Jul 2008
- Study completion1 Jul 2008
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 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
- 1,716 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
- Elieser Gorelik, MD, PhD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897546
- Sponsor's protocol ID
- CDR0000489213
- Other IDs
- ECOG-E1L06T1
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- Last updated
- 19 May 2017
- Results posted
- No
Publications
Yurkovetsky ZR, Kirkwood JM, Edington HD, Marrangoni AM, Velikokhatnaya L, Winans MT, Gorelik E, Lokshin AE. Multiplex analysis of serum cytokines in melanoma patients treated with interferon-alpha2b. Clin Cancer Res. 2007 Apr 15;13(8):2422-8. doi: 10.1158/1078-0432.CCR-06-1805.
PubMed 17438101
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
- Multiplex Analysis of Serum Biomarkers for Prediction Interferon Therapy Response in Melanoma Patients
- ClinicalTrials.gov ID
- NCT00897546
- Acronym / sponsor ID
- CDR0000489213
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,716 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 1 Jul 2008 (actual)
- Study completion
- 1 Jul 2008 (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: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.
Detailed description
OBJECTIVES:
- Generate a comprehensive multiplexed array of melanoma-associated serological markers and validate it using serum samples from patients with melanoma and healthy control participants.
- Determine changes in the profile of serological markers induced by interferon-alfa 2b (IFN-α2b) therapy.
- Define panels of serological markers with prognostic and predictive power for IFN-α2b therapy responses in patients with melanoma.
OUTLINE: This is a multicenter study.
Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines, chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin, vasostatin, and vascular endothelial growth factor inhibitor.
PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples submitted for research from patients participating in E1690 and 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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
Primary outcome
Generation of a comprehensive multiplexed array of melanoma-associated serological markers
Time frame: 1 month
Generation of a comprehensive multiplexed array of melanoma-associated serological markers
2 secondary outcomes
Changes in the profile of serological markers induced by interferon-alfa 2b therapy
Time frame: 1 month
Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response
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.
- Results publication: PubMed 17438101Yurkovetsky ZR, Kirkwood JM, Edington HD, Marrangoni AM, Velikokhatnaya L, Winans MT, Gorelik E, Lokshin AE. Multiplex analysis of serum cytokines in melanoma patients treated with interferon-alpha2b. Clin Cancer Res. 2007 Apr 15;13(8):2422-8. doi: 10.1158/1078-0432.CCR-06-1805.
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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.
Elieser Gorelik, MD, 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?
Generation of a comprehensive multiplexed array of melanoma-associated serological markers (time frame: 1 month). 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 NCT00897546, 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 19 May 2017.