En studie med humant papillomvirus (HPV) DNA-testning för att upptäcka HPV-relaterad orofaryngeal cancer (OPC)
En studie av användning av plasmacirkulerande cellfri humant papillomavirus deoxiribonukleinsyra för att screena (jfr HPV-DNA) för HPV-relaterad orofaryngeal cancer
The researchers think that a blood test (NavDx®) may be able to identify cancer early by looking for circulating DNA from Human Papillomavirus/HPV. Circulating DNA are small pieces of genes that are released into the bloodstream. The purpose of this study is to find out whether using this blood test to test for HPV DNA will help detect HPV-related Oropharyngeal Cancer/OPC.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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New Jersey
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Basking Ridge, New Jersey, Förenta staterna, 07920
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Middletown, New Jersey, Förenta staterna, 07748
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Montvale, New Jersey, Förenta staterna, 07645
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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New York
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Commack, New York, Förenta staterna, 11725
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
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Harrison, New York, Förenta staterna, 10604
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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New York, New York, Förenta staterna, 10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Uniondale, New York, Förenta staterna, 11553
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Potential research participants will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their participant's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential participants contacted by their treating physician will be referred to the investigator/research staff of the study
Beskrivning
Inclusion Criteria:
- Ages 45 and older
- Self-reported history of four or more lifetime sexual partners
- Self-reported history of one or more lifetime oral sexual partner
- No previous history of diagnosed HPV-related head and neck cancer
Exclusion Criteria:
- History of diagnosed HPV-related OPC
- Less than three sexual partners in lifetime
- No history of oral sex performed
- Younger than age 45
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
No previous history of diagnosed HPV-related head and neck cancer
Participants have no previous history of diagnosed HPV-related head and neck cancer |
Evaluation of HPV presence via NavDx (v1) at two (or three) timepoints o If one of the two blood samples is positive, the subject will have a third NavDx (v1) test approximately 1 month after the second timepoint. If the test is positive, the subject will move to surveillance phase. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants found to have HPV-related OPC
Tidsram: Up to 5 years
|
: The primary objective is to determine the feasibility of screening by estimating the yield (proportion of subjects found to have HPV-related OPC out of all subjects screened). |
Up to 5 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Nancy Lee, MD, Memorial Sloan Kettering Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 22-234
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Läkemedels- och apparatinformation, studiedokument
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