- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03051191
Pathogenic Mechanisms of Cancer and Cardiovascular Diseases
Exploring the Pathogenic Mechanisms Shared by Cancer and Cardiovasuclar Diseases
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
It has been reported that subjects with cardiovascular diseases (CVD) have higher incidence of cancers compared with general population. Because of the genetic and traditional commonalities between the underlying causes of CVD and cancers, the investigators hypothesized that shared molecular mechanism play a pivotal role in the pathogenesis of CVD including heart failure (HF) and cancers.
MicroRNAs (miRNAs) are small, single-stranded non-coding RNA sequences of about 18-22 nucleotides that interact with specific target messenger RNAs. They are known to be involved in the various processes including development, homeostasis, cell differentiation, proliferation, apoptosis and various diseases by modulating post-transcriptional and translational processes. Some of miRNAs have been reported to be involved in the pathogenesis of cancers. Cell free DNAs (cfDNA) is extracellular nucleic acids found in cell-free plasma in humans. Elevated level of cfDNA was reported in patients with cancer and CVD. 16S ribosomal RNA (rRNA) genes are distinct in microbiota, which can be utilized to quantify the bacterial DNA in the systemic circulation. 16S rRNA genes are also shown to be elevated in patients with CVD. These findings imply the possibility that translocated microbiota might play pivotal roles in the pathogenesis of CVD and cancers. The quantity and composition of gut microbiota have been shown to be altered in various diseases including obesity, diabetes mellitus, hypertension and CVD. The previous findings from fecal transplantation experiments, which showed the disease phenotype was transferred from one to another subject (animal or human), strongly suggest the possibility that microbiota play some pathogenic roles in those diseases.
To address this hypothesis, the investigators are going to cross-sectionally explore the expression pattern of miRNA and cfDNA and the composition of gut microbiota extensively in patients with or without atherosclerotic CVD (ACVD), non-ischemic HF (NIHF), and cancers. The investigators will recruit the participants from the patients who regularly visit the outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research. The investigators will recruit the patients without ACVD or NIHF and with/without cancers (Group 1/2), those with ACVD and with/without cancers (Group 3/4), and those with NIHF and with/without cancers (Group 5/6). Their peripheral blood will be drawn and stools will be collected. miRNA in exosome will be extracted from plasma and explored by miRNA microarray. cfDNA pattern will be extensively explored by microarray. By comparing the expression pattern of miRNA and cfDNA, and the composition of gut microbiota by 16s rRNA gene shotgun analysis, the investigators will be seeking to find the molecular mechanisms shared by those diseases.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Fuchu, Giappone, 183-0003
- Sakakibara Heart Institute
-
Tokyo, Giappone, 135-8550
- The Cancer Institute Hospital for Japanese Foundation for Cancer Research
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- subjects who regularly visit outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research.
Exclusion Criteria:
- subjects who have multiple cancers
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
1: No ACVD/NIHF or cancers
The patients who do not have ACVD, NIHF or cancers
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Altri nomi:
|
|
2: Cancers but no ACVD/NIHF
The patients who have cancers but no ACVD/NIHF
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Altri nomi:
|
|
3: ACVD and cancers
The patients who have ACVD and cancers
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Altri nomi:
|
|
4: ACVD but no cancers
The patients who have ACVD but no cancers
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Altri nomi:
|
|
5: NIHF and cancers
The patients who have NIHF and cancers
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Altri nomi:
|
|
6: NIHF but no cancers
The patients who have NIHF but no cancers
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
miRNA
Lasso di tempo: At enrollment
|
Expression pattern of miRNA in blood
|
At enrollment
|
|
Cell free DNA from host
Lasso di tempo: At enrollment
|
Quantity of cell free DNA derived from host in blood
|
At enrollment
|
|
Cell free DNA from microbiota
Lasso di tempo: At enrollment
|
Expression pattern of cell free DNA distinct from microbiota in blood
|
At enrollment
|
|
bacterial composition in stool
Lasso di tempo: At enrollment
|
the bacterial composition analyzed by shot gun analysis of 16s rRNA genes in stool
|
At enrollment
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Tsutomu Yoshikawa, Sakakibara Heart Institute
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SHIP02
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su micro RNA
-
Beni-Suef UniversityCompletato
-
University of Alabama at BirminghamRitiratoIpertensione polmonareStati Uniti
-
Benha UniversityCompletatoEndometriosi | Infertilità inspiegabileEgitto
-
Sohag UniversityReclutamentoTrombocitopenia immunitaria primariaEgitto
-
Jin YingNon ancora reclutamentoNeoplasie polmonari | Cancro al polmone, cellule non piccole
-
National Institute of Allergy and Infectious Diseases...Reclutamento
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); Department of Health and Human ServicesAttivo, non reclutante
-
SanofiAttivo, non reclutanteAtherosclerotic Cardiovascular Disease Without Prior Ischemic EventsStati Uniti
-
Cytrellis Biosystems, Inc.Iscrizione su invitoMigliori Pratiche | Ellacor | Cura Dopo Micro-coring | Ellacor Post CareStati Uniti