- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03302637
Oral Microbiome and Pancreatic Cancer
Oral Microbiome and Pancreatic Cancer: a Prospective Case-Control Study
This is a prospective population based study to examine the relationship of oral and pancreatic microbiome, and their functions, to pancreatic cancer risk.
The identification of specific oral bacteria and their functional relationship to pancreatic cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could provide a new microbially-based research paradigm, possibly leading to new drug targets for this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic preventions, with antibiotic therapy aimed at eradicating the specific species associated with increased cancer risk or, alternatively, combined with probiotics to introduce species that are associated with a decreased cancer risk. Thus, the study outcomes will lead to actionable means for pancreatic cancer prevention.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10016
- New York University School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- DNA extracted from oral wash samples from NIH-PLCO and ACS-CPS cohorts
Exclusion Criteria:
-
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Cases
subjects with histology-confirmed incident pancreatic cancer, with no prior history of cancer (except non-melanoma skin cancer), a valid consent, and pre-diagnostic oral wash samples.
|
extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit.
16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab.
Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.
|
Control
selected by incidence density sampling63 among cohort members who had no cancer prior to selection, provided a valid consent and an oral wash.
Controls were frequency matched to cases by cohort, age at cohort entry (5 year), sex, race, and calendar year of cohort entry.
|
extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit.
16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab.
Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.
Tidsram: 4 Years
|
For the taxa present at both sites, correlation between the abundance of taxa will be examined between the two sites.
To adjust for confounders, multivariate linear regression will be used with abundance of oral taxa (exposure) and that of pancreas taxa (outcome).
|
4 Years
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12-00721
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Bukspottskörtelcancer
-
Tianjin Medical University Cancer Institute and...Har inte rekryterat ännuPDAC - Pancreatic Ductal Adenocarcinoma
-
Sun Yat-sen UniversityRekryteringPDAC - Pancreatic Ductal AdenocarcinomaKina
-
Azienda Ospedaliera Universitaria Integrata VeronaRekryteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Cedars-Sinai Medical CenterRekryteringPDAC - Pancreatic Ductal AdenocarcinomaFörenta staterna
-
Azienda Ospedaliera Universitaria Integrata VeronaRekryteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Radboud University Medical CenterDutch Cancer SocietyRekryteringPDAC - Pancreatic Ductal AdenocarcinomaNederländerna
-
Imperial College LondonThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS... och andra samarbetspartnersRekryteringBukspottskörtelcancer | PDAC - Pancreatic Ductal AdenocarcinomaStorbritannien
-
Chinese PLA General HospitalRekryteringPankreatiska neoplasmer | Bukspottskörtelcancer | Bukspottkörtelcancer | PDAC - Pancreatic Ductal AdenocarcinomaKina
-
Andrei IagaruInte längre tillgängligKarcinoida tumörer | Islet Cell (Pancreatic NET) | Andra neuroendokrina tumörerFörenta staterna
-
Mayo ClinicRekryteringBukspottskörtelcancer | Duktalt adenokarcinom i bukspottkörteln | PDAC | PDAC - Pancreatic Ductal AdenocarcinomaFörenta staterna
Kliniska prövningar på 16S rRNA gene sequencing assay
-
Chinese University of Hong KongRekrytering
-
Gomel State Medical UniversityRekrytering
-
Hallym University Kangnam Sacred Heart HospitalRekryteringCoronavirusinfektioner | Tarmmikrobiom | Barndom ALLAKorea, Republiken av
-
University of TennesseeAvslutadBronkopulmonell dysplasiFörenta staterna
-
Reproductive Medicine Associates of New JerseyAvslutad
-
Konkuk University Medical CenterAvslutadGastrit | Mikrobiell koloniseringKorea, Republiken av
-
Qilu Hospital of Shandong UniversityAvslutadPankreatiskt duktalt adenokarcinom (PDAC)Kina
-
Shandong UniversityOkändMagtarmsmetaplasi | Slemhinnemikrobiom | DuodenumKina
-
Shandong UniversityOkändTarmmetaplasi | Slemhinnemikrobiom | H.Pylori | MagneoplasiKina
-
Atlas BiomedAvslutadParkinsons sjukdom | Genetisk predispositionRyska Federationen