- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02941029
RADTOX: Measuring Radiation Toxicity Using Circulating DNA (RADTOX)
Studieoversigt
Detaljeret beskrivelse
Currently, a patient's risk for toxicity is based almost exclusively on population statistics. Radiation (and chemotherapy) dose are based on phase I data and not on the individual's specific genetics or hidden predispositions. RadTox measures cell damage within 24 hours of radiation exposure and should help identify patients at higher risk for radiation complications. This should allow physicians to adjust radiation field size and dose to minimize long-term toxicity.
Patients undergoing radiation treatment for stage I to III prostate cancer, using protons or X-rays, either as primary treatment or consolidation after prostatectomy (positive margins or prostate-specific assay [PSA]-related indications) will be eligible. Hormone treatment will be allowed.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Florida
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Gainesville, Florida, Forenede Stater, 32610
- University of Florida Health
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Jacksonville, Florida, Forenede Stater, 32206
- University of Florida Health Proton Therapy Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Consent to participate in the study and a signed and dated an institutional review board (IRB)-approved consent form conforming to federal and institutional guidelines.
- ≥ 18 years of age.
- Patients must have an Eastern Cooperative Oncology Group (An ECOG) performance status of 0 or 1.
- A diagnosis of adenocarcinoma of the prostate.
- Not yet begun definitive therapy with chemotherapy or radiation but may have hormones or surgery.
- Clinically stage I to III tumors.
Exclusion Criteria:
- Metastatic disease.
- A history of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
- Active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic).
- Prior pelvic radiation therapy for any reason.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the principal investigator (PI), would preclude the patient from meeting the study requirements.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Evaluate toxicity biomarkers
Investigators will determine if measurement of circulating DNA from tumor and normal tissues shortly after RT provides an early and quantitative measure of risk of radiation-related complications.
It will be necessary to collect blood specimens prior to and during the first week of radiation therapy.
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Plasma blood collection is collected at specific intervals prior to and during radiation treatment.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared to CTCAE v4.0
Tidsramme: 9 Months
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9 Months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared pain scores
Tidsramme: 9 Months
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9 Months
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Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared and visual analog scales of toxicity
Tidsramme: 9 Months
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9 Months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Randal Henderson, MD, MBA, clinical professor
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB201601961-N
- 261201600063C-0-0-1 (U.S. NIH-bevilling/kontrakt)
- OCR15535 (Anden identifikator: OnCore)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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