En undersøgelse med human papillomavirus (HPV) DNA-test til at påvise HPV-relateret oropharyngeal cancer (OPC)
En undersøgelse af brug af plasmacirkulerende cellefri human papillomavirus deoxyribonukleinsyre til at screene (jf. HPV DNA) for HPV-relateret 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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New Jersey
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Basking Ridge, New Jersey, Forenede Stater, 07920
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Middletown, New Jersey, Forenede Stater, 07748
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Montvale, New Jersey, Forenede Stater, 07645
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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New York
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Commack, New York, Forenede Stater, 11725
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
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Harrison, New York, Forenede Stater, 10604
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Uniondale, New York, Forenede Stater, 11553
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants found to have HPV-related OPC
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Nancy Lee, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
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
- 22-234
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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