- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00897520
Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Tilbagevirkende kraft
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serum sample screening via high throughput protein profiling in patients undergoing therapy
Tidsramme: 1 month
|
1 month
|
|
Comparison of soluble factors
Tidsramme: 1 month
|
1 month
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Monica Panelli, PhD, University of Pittsburgh
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroendokrine tumorer
- Nevi og melanomer
- Melanom
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antivirale midler
- Antineoplastiske midler
- Immunologiske faktorer
- Interferoner
- Interferon-alfa
Andre undersøgelses-id-numre
- CDR0000585297
- ECOG-E1694T1
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