- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05037825
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors (PARADIGM)
25. april 2022 oppdatert av: VastBiome
The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy.
Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses.
However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes.
The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Forventet)
800
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hanane Arib, MS
- Telefonnummer: 650-479-5539
- E-post: Hanane@vastbiome.com
Studer Kontakt Backup
- Navn: Peter McCaffrey, MD
- Telefonnummer: 650-479-5539
- E-post: Peter@vastbiome.com
Studiesteder
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Kentucky
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Elizabethtown, Kentucky, Forente stater, 42701
- Rekruttering
- Baptist Health Clinical Research
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Ta kontakt med:
- Diane Drobny, BSN, RN, OCN, CCRP
- Telefonnummer: (270) 706-5470
- E-post: Delores.Drobny@bhsi.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The investigator propose to enroll 800 cancer patients (NSCLC, MM, RCC, and TNBC; any stage) who are about to begin standard of care ICI therapy into a multi-site prospective observational study of the gut microbiome.
Beskrivelse
Inclusion Criteria:
- Men or women ≥18 years of age
- Screened negative for COVID-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the COVID-19 pandemic
- Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
- Plan to be treated at a partner cancer site with a checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti-CTLA-4) as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent
- Able to provide informed consent and answer study questionnaires in either English or Spanish
- Able to provide stool specimens for research purposes
Exclusion Criteria:
- Mental incapacity
- Incarcerated individuals
- Pregnancy (by self-report of pregnancy status)
- Experiencing active brain metastasis/metastases
- Treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial
- Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in microbiome composition from baseline to after Cycle 2 of checkpoint therapy (6-8 weeks) by analyzing longitudinally-collected stool specimens of 800 patients with primary NSCLC, MM, RCC, and TNBC
Tidsramme: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 of checkpoint blockade immunotherapy (at approximately 6-8 weeks) ]
|
Microbiome evaluation with whole metagenome shotgun sequencing to assess changes in the relative abundance of microbial taxa (measured as percentage abundance per microbial species and changes in percentage abundance between baseline and cycle 2 timepoints) in patients who are receiving checkpoint blockade immunotherapy as the standard of care
|
prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 of checkpoint blockade immunotherapy (at approximately 6-8 weeks) ]
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Microbiome samples correlation
Tidsramme: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
|
Definition of a correlation between the gut microbiome and circulating cytokines (specifically IL-2, IL-10, TNF-alpha, IFN-gamma, and G-CSF) and therapeutic response (defined using RECIST criteria).
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Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
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Microbiome correlation to blood biomarkers
Tidsramme: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
|
Definition of a correlation between the gut microbiome (measured as percent abundance of microbial taxa derived from whole-metagenome shotgun sequencing) and plasma metabolites (measured in m/z and peak intensities and--where possible--compound abundances in ng/mL) and circulating cytokines (measured in pg/mL per cytokine) in patients receiving checkpoint blockade immunotherapy.
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Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
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Blood samples correlation
Tidsramme: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
|
Definition of a correlation between plasma metabolites (measured in m/z and peak intensities and--where possible--compound abundances in ng/mL) and circulating cytokines (measured in pg/mL per cytokine) and therapeutic response (defined using RECIST criteria).
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Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
22. november 2021
Primær fullføring (Forventet)
14. september 2023
Studiet fullført (Forventet)
14. september 2028
Datoer for studieregistrering
Først innsendt
2. august 2021
Først innsendt som oppfylte QC-kriteriene
2. september 2021
Først lagt ut (Faktiske)
8. september 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Neoplasmer
- Lungesykdommer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Nyresykdommer
- Urologiske sykdommer
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Bryst sykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Nyre-neoplasmer
- Lungeneoplasmer
- Nevroendokrine svulster
- Nevi og melanomer
- Brystneoplasmer
- Karsinom, nyrecelle
- Karsinom, ikke-småcellet lunge
- Karsinom
- Melanom
- Trippel negative brystneoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Immune Checkpoint-hemmere
Andre studie-ID-numre
- Pro00054854
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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