Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Melanoma (Skin) |
Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Multiplex Analysis of Serum Biomarkers for Prediction Interferon Therapy Response in Melanoma Patients |
- Generation of a comprehensive multiplexed array of melanoma-associated serological markers [ Designated as safety issue: No ]
- Changes in the profile of serological markers induced by interferon-alfa 2b therapy [ Designated as safety issue: No ]
- Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response [ Designated as safety issue: No ]
| Estimated Enrollment: | 1716 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
- Diagnosis of melanoma OR healthy volunteer (control)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00897546 History of Changes |
| Other Study ID Numbers: | CDR0000489213, ECOG-E1L06T1 |
| Study First Received: | May 9, 2009 |
| Last Updated: | August 20, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Interferons Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 18, 2013