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Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies

2. februar 2021 opdateret af: Exact Sciences Corporation
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Subjects will have been recently diagnosed with an untreated hematologic malignancy. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

409

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72903
        • Mercy Fort Smith
      • Little Rock, Arkansas, Forenede Stater, 72205
        • CARTI Cancer Center
    • California
      • Greenbrae, California, Forenede Stater, 94904
        • Marin Cancer Care
      • Laguna Hills, California, Forenede Stater, 92653
        • Alliance Research Centers
      • Oceanside, California, Forenede Stater, 92056
        • North County Oncology
    • Connecticut
      • Middletown, Connecticut, Forenede Stater, 06457
        • Middlesex Hospital
      • Stamford, Connecticut, Forenede Stater, 06904
        • The Stamford Hospital
    • Florida
      • Orange City, Florida, Forenede Stater, 32765
        • Mid-Florida Hematology and Oncology Center
    • Illinois
      • Downers Grove, Illinois, Forenede Stater, 60515
        • PMG Research, Inc
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Skokie, Illinois, Forenede Stater, 60077
        • Orchard Healthcare Research, Inc.
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center NCI
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46237
        • Indiana Blood and Marrow Transportation
    • Kentucky
      • Edgewood, Kentucky, Forenede Stater, 41017
        • St. Elizabeth Medical Center
      • Lexington, Kentucky, Forenede Stater, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, Forenede Stater, 40207
        • Baptist Health Louisville
      • Paducah, Kentucky, Forenede Stater, 42003
        • Baptist Health Paducah
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20817
        • RCCA MD Inc.
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Cancer Research Consortium of West Michigan
    • Minnesota
      • Bloomington, Minnesota, Forenede Stater, 55425
        • HealthPartner Institute
    • Missouri
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Joplin
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Mercy St. Louis
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Springfield
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27834
        • East Carolina University Brody School of Medicine
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • FirstHealth Outpatient Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Mercy Oklahoma City
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29607
        • Bon Secours St Francis Cancer Center
      • Spartanburg, South Carolina, Forenede Stater, 29301
        • Spartanburg Regional Healthcare District
      • West Columbia, South Carolina, Forenede Stater, 29169
        • Lexington Medical Center
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Community Cancer Trials of Utah
    • Washington
      • Wenatchee, Washington, Forenede Stater, 98801
        • Wenatchee Valley Hospital
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • CAMC Clinical Trials Center
    • Wisconsin
      • Fort Atkinson, Wisconsin, Forenede Stater, 53538
        • Dean Clinic - Fort Atkinson Specialty Services
      • Oconomowoc, Wisconsin, Forenede Stater, 53066
        • ProHealth Care

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

Approximately 500 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated hematologic malignancy.

Beskrivelse

Inclusion Criteria:

  • Subject is male or female ≥ 18 years of age.
  • Subject has an untreated hematologic malignancy.
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
  • Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  • Any treatment for the primary malignancy. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment prior to blood sample collection.
  • Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  • Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
  • IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

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: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Hematologic Malignancy
Subjects with clinically confirmed hematologic malignancy and who are treatment naive will provide a blood sample at the time of enrollment. No additional blood draws will occur.
Andet: Blodprøvesamling
Forsøgspersoner, der deltager i undersøgelsen, vil få udtaget blod ved tilmelding.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood-based biomarkers associated with genetic and epigenetic alterations.
Tidsramme: Point in time blood collection (1 day) at enrollment
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with a hematologic malignancy at the pre-intervention stage.
Point in time blood collection (1 day) at enrollment

Samarbejdspartnere og efterforskere

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

Sponsor

Exact Sciences Corporation

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)

7. december 2018

Primær færdiggørelse (Faktiske)

24. marts 2020

Studieafslutning (Faktiske)

24. marts 2020

Datoer for studieregistrering

Først indsendt

23. oktober 2018

Først indsendt, der opfyldte QC-kriterier

30. oktober 2018

Først opslået (Faktiske)

1. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2018-02

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.

IPD-delingstidsramme

Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

IPD-delingsadgangskriterier

Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Formular til informeret samtykke (ICF)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 Blodprøvesamling

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bosnia & Herzegovina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner