- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00045331
Study in Predicting Outcome of Patients Undergoing Radiation Therapy for Prostate Cancer
Are the Proteomic Profiles of Serum and Urine Predictivefor Clinical Outcome After Definitive Radiotherapy for Localized Prostate Cancer? A Preliminary Cohort Study
RATIONALE: Proteins found in blood and urine samples may help predict outcome and allow doctors to plan more effective treatment.
PURPOSE: Diagnostic trial to study blood and urine proteins in predicting treatment outcome in patients who are undergoing radiation therapy for prostate cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Correlate serum and urine protein profiles collected before or after radiotherapy with clinical outcome in patients with prostate cancer.
- Identify protein profiles that can distinguish between patients with no evidence of disease and those with biochemical and/or clinical failure.
- Determine whether those serum proteomic profiles consistent with failure can be identified at early time points in the course of treatment and follow-up of these patients.
OUTLINE: Patients are stratified according to clinical outcome (prior to radiotherapy vs no evidence of disease vs biochemical failure vs clinical failure vs clinical outcome not yet determined).
Urine and blood specimens are collected from patients either before or after definitive radiotherapy. Samples are analyzed by surface-enhanced laser desorption and ionization time-of-flight mass spectrometry to develop proteomic patterns.
Results of proteomic profiles do not influence patient care.
PROJECTED ACCRUAL: A total of 150 patients (30 per stratum) will be accrued for this study.
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Bethesda, Maryland, Forenede Stater, 20892
- NCI - Center for Cancer Research
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Completed or planned definitive radiotherapy
PATIENT CHARACTERISTICS:
Age
- Adult
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Concurrent immunotherapy allowed
Chemotherapy
- Concurrent chemotherapy allowed
Endocrine therapy
- Concurrent hormonal therapy allowed
Radiotherapy
- See Disease Characteristics
- Concurrent palliative radiotherapy allowed
Surgery
- No prior prostatectomy, including radical prostatectomy
- No concurrent radical prostatectomy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Kevin Camphausen, MD, NCI - Radiation Oncology Branch; ROB
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000256868
- NCI-02-C-0226
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Kliniske forsøg med proteomisk profilering
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Karolinska InstitutetMbarara University of Science and Technology; Science for Life Laboratory; Epicentre Mbarara Research Center og andre samarbejdspartnereAfsluttet