Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing

15. maj 2019 opdateret af: Inivata

Prospective Observational Study to Evaluate the Performance of Inivata Liquid Biopsy Analysis Compared With Standard Tissue Biopsy Analysis for Detection of Genomic Alterations in Patients With Advanced Non-small Cell Lung Cancer.

The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer. Once selected for the study and with full informed consent, patients will have a blood draw to allow the detection of cancer-related genomic alterations that are detectable within the blood sample. These results will be compared to results obtained from genomic profiling via standard tissue biopsy taken as part of routine care to help determine whether such 'liquid biopsies' can be used to guide treatments in future patients. The results of the liquid biopsy will not be used to guide treatment decisions in study participants.

In addition there is data-collection of treatments received for non small cell lung cancer and the response to these treatments during the first 6 months post tissue and blood analysis, though no additional visits or procedures are required for the patient beyond the initial blood draw.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

264

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Mission Hills, California, Forenede Stater, 91345
        • FACEY Medical Foundation
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Cancer Center
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360
        • Eastern CT Hematology Oncology
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Christiana Care Health Services Inc
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Holy Cross Hospital
      • Orange City, Florida, Forenede Stater, 32763
        • Mid-Florida Hematology and Oncology Centers
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60625
        • Swedish Covenant Hospital
      • Skokie, Illinois, Forenede Stater, 60076
        • Edward M Kaplan, MD & Associates
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Cotton O'Neil Clinical Research Center
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Norton Healthcare Inc
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71105
        • Christus Cancer Treatment Center
    • Massachusetts
      • Pittsfield, Massachusetts, Forenede Stater, 01201
        • Berkshire Hematology Oncology Services
    • Michigan
      • Jackson, Michigan, Forenede Stater, 49201
        • Henry Ford Allegiance Health
    • Minnesota
      • Saint Louis Park, Minnesota, Forenede Stater, 55426
        • Park Nicolett
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • Jackson Oncology Associates, PLLC
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
        • Boone Hospital Center
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University (St. Louis)
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Nebraska Methodist Hospital
    • New York
      • East Setauket, New York, Forenede Stater, 11733
        • Northshore Hematology Oncology
      • Mount Kisco, New York, Forenede Stater, 10549
        • Northern Westchester Hospital Association
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27834
        • East Carolina University
      • Mint Hill, North Carolina, Forenede Stater, 28227
        • Levine Cancer Center
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • Pinehurst Medical Clinic
    • North Dakota
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Cancer Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Health and Services
    • Pennsylvania
      • Gettysburg, Pennsylvania, Forenede Stater, 17325
        • Gettysburg Cancer Center
    • South Carolina
      • Rock Hill, South Carolina, Forenede Stater, 29732
        • Carolina Blood and Cancer Care
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • The West Clinic
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Tennessee Cancer Specialists
    • Texas
      • Corpus Christi, Texas, Forenede Stater, 78412
        • Thomas Spann Clinic Oncology
      • Tyler, Texas, Forenede Stater, 75701
        • Hope Cancer Center of East Texas (Tyler Hem Onc)
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23226
        • Virginia Cancer Institute
    • Washington
      • Everett, Washington, Forenede Stater, 98201
        • Providence Regional Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • University of Washington (Swedish General)
      • Tacoma, Washington, Forenede Stater, 98405
        • Northwest Medical Specialties

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC, who are intended to initiate first-line treatment according to standard guidelines, or having recently progressed on first-line EGFR or ALK directed therapy and being considered for further therapy.

Beskrivelse

Inclusion Criteria:

  • Written, signed and dated informed consent to participate in the study must be given by the patient in accordance with 21 CFR Part 312, the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable regulations, before completing any study-related procedures.
  • Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
  • Arms A and B: Patients intended to initiate first-line treatment according to standard guidelines. Note, a patient is eligible to receive sterotactic radiosurgery (no whole-brain radiotherapy). Arm C: Patients who are at a second-line treatment setting or greater may participate. Note, a patient may be included if they have metastatic brain lesions. Arms A, B, C: If enrolled in a treatment clinical trial, patients may also enroll in this study if all eligibility criteria are met.
  • Arm A only: Patients intended to initiate first-line treatment according to standard guidelines who plan to have or have had a recent tumor tissue biopsy taken for molecular profiling as part of their standard of care.
  • Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.

Exclusion Criteria:

  • Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy (Arms A and B)
  • Patients who have any other prior metastatic or current second primary cancer (Arms A and B)
  • Patient who has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Tidsramme
Detection: sensitivity and specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
Tidsramme: 1 year
1 year
Proportion of NSCLC patients eligible for targeted therapy based on liquid biopsy analysis as an evaluation of feasibility molecular stratification, compared to standard of care alone
Tidsramme: 1 year
1 year
Progression free survival (PFS) rate over 6 months
Tidsramme: 1 year
1 year
Overall survival (OS) rate over 6 months
Tidsramme: 1 year
1 year

Andre resultatmål

Resultatmål
Tidsramme
Relationship of clinical response to therapy with mutation allele frequency (MAF) cutoff in Inivata liquid biopsy assay
Tidsramme: 1 year
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Inivata

Samarbejdspartnere

Vector Oncology

Efterforskere

  • Ledende efterforsker: Ramaswamy Govindan, MD, Washington University School of Medicine
  • Ledende efterforsker: Edward Kim, MD, Levine Cancer Institute
  • Studieleder: Clive Morris, MD, Inivata

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2016

Primær færdiggørelse (Faktiske)

31. maj 2018

Studieafslutning (Faktiske)

31. december 2018

Datoer for studieregistrering

Først indsendt

2. september 2016

Først indsendt, der opfyldte QC-kriterier

14. september 2016

Først opslået (Skøn)

20. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INI001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ikke-småcellet lungekræft

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner