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Skjold etter godkjenningsstudieprotokoll (SOLAR)

11. november 2026 oppdatert av: Guardant Health, Inc.

The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.

Studieoversikt

Detaljert beskrivelse

Colorectal cancer (CRC) is the fourth most diagnosed cancer and second leading cause of cancer-related death in the US, with an estimated 53,010 deaths attributable to CRC in 2024. The risk of CRC increases with age, with the majority of cases and deaths occurring in individuals aged 65 years or older. While the incidence of CRC in Americans 65 years of age or older has decreased over the last decade, the incidence of CRC in younger Americans aged 55 years or younger has been increasing since the mid-1990s. CRC disproportionately affects minority populations, with American Indian/Alaska Native and Black/African American populations having the highest incidence and mortality rates1; this is further exacerbated by systemic barriers to current CRC screening options.

CRC primarily arises from a precursor lesion, the adenomatous polyp (i.e., adenoma), that grows from the epithelial cells of the colorectal mucosa. Adenomas that grow larger than 10 mm or have elements indicating a risk of malignant transformation (e.g., high-grade dysplasia or villous features) are defined as advanced adenomas (AAs). The vast number of adenomas, even those with features classifying them as AAs, do not progress into a colorectal malignancy. Colonoscopy cannot always distinguish adenomas or advanced adenomas from other polyp histology; thus, polypectomy is routinely performed for lesions identified on endoscopy. The transition rate from adenoma onset to CRC development is estimated to be 12.5 to 25 years. This slow transition from adenoma onset to CRC onset allows for multiple CRC screening opportunities over a lifetime, providing the ability to intervene along the disease development course and the potential to detect and remove adenomas, prevent colorectal cancer, and reduce CRC incidence and subsequently, disease mortality.

Once CRC has developed, tumor staging is consistent with other solid tumors and defined based on how far the cancer has spread within the body. In Stage 0 (carcinoma in situ), the cancer cells are only in the colorectal mucosa. In Stage I, the cancer has spread to the muscular layer of the colorectum but not to nearby tissue or lymph nodes. In Stage II, the cancer has grown through the wall of the colorectum and potentially to nearby tissues but has not spread to nearby lymph nodes. In Stage III, the cancer has spread to nearby lymph nodes but not to distant parts of the body. In Stage IV, the cancer has spread to one or more distant parts of the body. The estimated time frame from CRC onset to a symptomatic diagnosis of CRC is estimated to be 4-5 years, in the absence of early detection through asymptomatic cancer screening. Tumor size and location can influence the rate of transition through the stages of CRC. The 5-year survival rate for localized disease (Stage I-II) is 91%, and is 72% for regional disease (Stage III), while the 5-year survival for metastatic disease (Stage IV) is only 14%. These statistics highlight the ability to reduce CRC-related mortality by detection of early-stage (Stage I-III) disease where therapeutic intervention has the potential to result in a cure.

Studietype

Observasjonsmessig

Registrering (Antatt)

3375

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Arizona
      • Chandler, Arizona, Forente stater, 85224
        • Rekruttering
        • Southeast Valley Gastroenterology Consultants
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles Schron
      • Gilbert, Arizona, Forente stater, 85297
        • Rekruttering
        • Southeast Valley Gastroenterology Consultants
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles Schron
    • California
      • Anaheim, California, Forente stater, 92805
        • Rekruttering
        • Elite Primary Physicians, Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ishminder Singh, MD
      • Canoga Park, California, Forente stater, 91304
        • Rekruttering
        • Alliance Research Institute, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Cameron Sikavi
      • Garden Grove, California, Forente stater, 92840
        • Tilbaketrukket
        • Paragon Rx Clinical, Inc.
      • Granada Hills, California, Forente stater, 91344
        • Rekruttering
        • Amicis Research Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Pascal Dabel
      • Monterey Park, California, Forente stater, 91754
        • Rekruttering
        • Ace Research Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Yu-Hsiang Sam Lee, MD
      • Palm Springs, California, Forente stater, 92262
        • Rekruttering
        • Desert Oasis Healthcare Medical Group
        • Hovedetterforsker:
          • Michael F Jardula
        • Ta kontakt med:
      • Sherman Oaks, California, Forente stater, 91403
        • Rekruttering
        • Amicis Research Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ali Sheybani, MD
      • Tarzana, California, Forente stater, 91356
        • Rekruttering
        • BioPartners, Inc
        • Ta kontakt med:
          • Mila Gor
          • Telefonnummer: 818-712-9355
        • Hovedetterforsker:
          • Arkady Stern, MD
      • Valencia, California, Forente stater, 91355
        • Rekruttering
        • Amicis Research Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dennis Lewis, MD
      • Winnetka, California, Forente stater, 91306
        • Rekruttering
        • Coral Clinics
        • Ta kontakt med:
        • Hovedetterforsker:
          • Amin Khorsandi, MD
      • Woodland Hills, California, Forente stater, 91367
        • Rekruttering
        • BioPartners, Inc
        • Hovedetterforsker:
          • Arkady Stern, MD
        • Ta kontakt med:
    • Connecticut
      • Branford, Connecticut, Forente stater, 06405
        • Rekruttering
        • Digestive Disease Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • Daniel Zanchetti
        • Ta kontakt med:
        • Hovedetterforsker:
          • Daniel Zanchetti, MD
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Rekruttering
        • Gastroenterology Consultants of Boca Raton, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Todd Eisner
      • Delray Beach, Florida, Forente stater, 33484
        • Rekruttering
        • Manuel Espinel MD PA
        • Ta kontakt med:
        • Hovedetterforsker:
          • Manuel Espinel, MD
      • Doral, Florida, Forente stater, 33172
        • Rekruttering
        • Innova Pharma Research, LLC
        • Hovedetterforsker:
          • Giralt Yanez, MD
        • Ta kontakt med:
      • Miami, Florida, Forente stater, 33134
        • Rekruttering
        • Research Associates of South Florida, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christian Andrade, MD
      • Miami, Florida, Forente stater, 33134
        • Rekruttering
        • Marisela Gonzalez, MD
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marisela Gonzalez, MD
      • Miami, Florida, Forente stater, 33166
        • Rekruttering
        • Florida South Research Phase I-IV, Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Eduardo Viera, MD
      • North Miami, Florida, Forente stater, 33181
        • Rekruttering
        • Physicians Group of South Florida
        • Ta kontakt med:
        • Hovedetterforsker:
          • Daniel Wolfson
      • Tamarac, Florida, Forente stater, 33321
        • Rekruttering
        • Infinity Life Research Group, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lazaro Diaz, MD
      • Tampa, Florida, Forente stater, 33607
        • Rekruttering
        • NMC Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Osvanny Nodal, MD
      • Tampa, Florida, Forente stater, 33634
        • Rekruttering
        • Top Research of West Florida, LLC
        • Hovedetterforsker:
          • Jorge Castillo Molina, MD
        • Ta kontakt med:
    • Georgia
      • Conyers, Georgia, Forente stater, 30094
        • Rekruttering
        • Keith Family Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nabil Keith, MD
      • Dawsonville, Georgia, Forente stater, 30534
        • Rekruttering
        • Keith Family Medicine
        • Hovedetterforsker:
          • Nabil Keith, MD
        • Ta kontakt med:
      • Fayetteville, Georgia, Forente stater, 30214
        • Rekruttering
        • Primeway Clinical Research Group
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charlita Worthy, MD
      • Snellville, Georgia, Forente stater, 30078
        • Rekruttering
        • CLINsearch at Renew Health Clinical Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ayyaz Qureshi, MD
    • Illinois
      • Bourbonnais, Illinois, Forente stater, 60914
        • Rekruttering
        • Digestive Disease Consultants
        • Hovedetterforsker:
          • Ashish Shah, MD
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ashish Shah
      • Champaign, Illinois, Forente stater, 61822
      • Champaign, Illinois, Forente stater, 61822
        • Aktiv, ikke rekrutterende
        • Christie Clinic
      • Chicago, Illinois, Forente stater, 60631
        • Rekruttering
        • GI Solutions of Illinois
        • Hovedetterforsker:
          • Charles Berkelhammer, MD
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles Berkelhammer
        • Ta kontakt med:
      • Downers Grove, Illinois, Forente stater, 60515
        • Rekruttering
        • Digestive Health Services
        • Hovedetterforsker:
          • Charles Berkelhammer, MD
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles Berkelhammer
        • Ta kontakt med:
      • Lake Barrington, Illinois, Forente stater, 60010
        • Rekruttering
        • Gastroenterology and Internal Medicine Specialists (GAIMS)
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nicole Gentile
        • Hovedetterforsker:
          • Nicole Gentile, MD
      • Libertyville, Illinois, Forente stater, 60048
        • Rekruttering
        • Northshore Center for Gastroenterology (NCG)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nicole Gentile, MD
      • Oak Lawn, Illinois, Forente stater, 60453
        • Rekruttering
        • Southwest Gastroenterology (SWG)
        • Hovedetterforsker:
          • Charles Berkelhammer, MD
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles Berkelhammer
        • Ta kontakt med:
    • Indiana
      • Munster, Indiana, Forente stater, 46321
        • Rekruttering
        • Center for Digestive Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Navin Kumar, MD
    • Kansas
      • Hutchinson, Kansas, Forente stater, 67502
        • Aktiv, ikke rekrutterende
        • Hutchinson Clinic
    • Louisiana
      • Covington, Louisiana, Forente stater, 70433
        • Rekruttering
        • Northlake Gastroenterology Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gregory Mula
      • Hammond, Louisiana, Forente stater, 70403
        • Rekruttering
        • Northlake Gastroenterology Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gregory Mula
    • Maryland
      • Olney, Maryland, Forente stater, 20832
        • Rekruttering
        • Olney Medical Group
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gaurang Thaker, MD
    • Michigan
      • Bloomfield Township, Michigan, Forente stater, 48302
        • Rekruttering
        • Embassy Research Network
        • Ta kontakt med:
        • Hovedetterforsker:
          • Priyesh Patel, MD
      • Clarkston, Michigan, Forente stater, 48346
        • Rekruttering
        • Tanir Medical Center, PC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Narin Tanir-Avci, MD
    • Mississippi
      • Ridgeland, Mississippi, Forente stater, 39157
        • Rekruttering
        • Quinn Healthcare, PLLC
        • Hovedetterforsker:
          • Timothy Quinn, MD
        • Ta kontakt med:
    • New Jersey
      • Clifton, New Jersey, Forente stater, 07013
        • Rekruttering
        • Gastroenterology Associates of New Jersey, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Steven Gronowitz
      • Hackensack, New Jersey, Forente stater, 07601
        • Aktiv, ikke rekrutterende
        • Gastroenterology Associates of New Jersey
      • Montclair, New Jersey, Forente stater, 07042
        • Rekruttering
        • Gastroenterology Associates of New Jersey, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Steven Gronowitz
      • Ridgewood, New Jersey, Forente stater, 07450
        • Rekruttering
        • Gastroenterology Associates of New Jersey, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Steven Gronowitz
      • Wayne, New Jersey, Forente stater, 07470
        • Rekruttering
        • Gastroenterology Associates of New Jersey, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Steven Gronowitz
      • Wayne, New Jersey, Forente stater, 07470
        • Aktiv, ikke rekrutterende
        • Gastroenterology Associates of New Jersey
    • New York
      • Camillus, New York, Forente stater, 13031
        • Rekruttering
        • Associated Gastroenterologists of Central New York
        • Hovedetterforsker:
          • John Sun
        • Ta kontakt med:
      • East Syracuse, New York, Forente stater, 13057
        • Rekruttering
        • Syracuse Gastroenterological Associates, P.C.
        • Hovedetterforsker:
          • Dennis Reedy
        • Ta kontakt med:
      • Fayetteville, New York, Forente stater, 13066
        • Rekruttering
        • Associated Gastroenterologists of Central New York
        • Hovedetterforsker:
          • John Sun
        • Ta kontakt med:
      • New York, New York, Forente stater, 10010
        • Rekruttering
        • NYU Langone
        • Ta kontakt med:
        • Hovedetterforsker:
          • Peter Liang, MD
      • Orchard Park, New York, Forente stater, 14127
        • Rekruttering
        • Orchard Park Family Practice
        • Ta kontakt med:
        • Hovedetterforsker:
          • Richard Ruh
      • Valley Stream, New York, Forente stater, 11581
        • Rekruttering
        • GastroCare LI
        • Hovedetterforsker:
          • Brandon Rieders
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brandon Rieders, MD
    • North Carolina
      • Cary, North Carolina, Forente stater, 27518
        • Rekruttering
        • Cary Gastroenterology Associates
        • Hovedetterforsker:
          • Michael Brody
        • Ta kontakt med:
      • Chapel Hill, North Carolina, Forente stater, 27599
        • Rekruttering
        • University of North Carolina at Chapel Hill
        • Hovedetterforsker:
          • Sarah McGill, MD
        • Ta kontakt med:
      • Chapel Hill, North Carolina, Forente stater, 27514
        • Rekruttering
        • University of North Carolina at Chapel Hill
        • Hovedetterforsker:
          • Sarah McGill, MD
        • Ta kontakt med:
      • Hillsborough, North Carolina, Forente stater, 27278
        • Rekruttering
        • University of North Carolina at Chapel Hill
        • Hovedetterforsker:
          • Sarah McGill, MD
        • Ta kontakt med:
      • Mocksville, North Carolina, Forente stater, 27028
        • Aktiv, ikke rekrutterende
        • Piedmont Healthcare, P.A.
      • Pinehurst, North Carolina, Forente stater, 28374
        • Tilbaketrukket
        • Pinehurst Medical Clinic
      • Sanford, North Carolina, Forente stater, 27330
        • Tilbaketrukket
        • Sanford Cardiology Pinehurst Medical Clinic
      • Statesville, North Carolina, Forente stater, 28625
        • Aktiv, ikke rekrutterende
        • Piedmont Healthcare LLC
    • Pennsylvania
      • Altoona, Pennsylvania, Forente stater, 16602
        • Rekruttering
        • US Digestive Health at Blair
        • Hovedetterforsker:
          • Mitul Patel
        • Ta kontakt med:
      • Philadelphia, Pennsylvania, Forente stater, 19104
      • Pottstown, Pennsylvania, Forente stater, 19464
        • Rekruttering
        • Health Living at Pottstown Medical Specialists, Inc
        • Ta kontakt med:
        • Hovedetterforsker:
          • Wade Brosius
    • Texas
      • Austin, Texas, Forente stater, 78735
        • Aktiv, ikke rekrutterende
        • Premier Family Physicians
      • Austin, Texas, Forente stater, 78746
        • Aktiv, ikke rekrutterende
        • Premier Family Physicians
      • Garland, Texas, Forente stater, 75043
        • Rekruttering
        • Broadway Medical Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mohammed Al-Haider, MD
      • Houston, Texas, Forente stater, 77090
        • Rekruttering
        • Integrity Advanced Therapeutics, PLLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Howard Hamat
      • Paris, Texas, Forente stater, 75460
        • Rekruttering
        • Paris Family Physicians
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alois Pauls, MD
      • Shenandoah, Texas, Forente stater, 77384
        • Rekruttering
        • Center for Digestive Disease
        • Hovedetterforsker:
          • Shail Maheshwari
        • Ta kontakt med:
      • Tomball, Texas, Forente stater, 77375
        • Rekruttering
        • Horizon Clinical Research Group
        • Hovedetterforsker:
          • Amar Dodda
        • Ta kontakt med:
        • Hovedetterforsker:
          • Amar Dodda, MD
    • Virginia
      • Williamsburg, Virginia, Forente stater, 23188
        • Rekruttering
        • Tidewater Physician Multispecialty Group Clinical Research
        • Hovedetterforsker:
          • Frances Jones
        • Ta kontakt med:

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

45 år til 81 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study

Beskrivelse

Inclusion Criteria:

  1. Subjects aged 45-81 years at time of consent
  2. Intending to undergo a standard of care Shield test
  3. Considered by a physician or healthcare provider as being of 'average risk' for CRC; 'Average-risk' individuals in the context of CRC screening are defined as those who do not have symptoms of CRC and do not have increased risk factors for the disease (i.e., prior diagnosis of CRC, adenomatous polyps, or inflammatory bowel disease; family history of CRC or known hereditary predisposition to CRC).
  4. Subject agrees to comply with study procedures and associated standard of care assessments.

Exclusion Criteria:

  1. Undergoing colonoscopy for investigation of symptoms

  2. Personal history of colorectal cancer (CRC), adenomas, or other related cancers

  3. Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age

  4. Positive result on another colorectal cancer screening method within the last six months, or:

    • 12 months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT)
    • 36 months for FIT-DNA test
  5. Personal history of any of the following high-risk conditions for colorectal cancer:

    • Inflammatory Bowel Disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease

    • Familial adenomatous polyposis (FAP)

    • Other hereditary cancer syndromes including but not limited to:

      • Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or "Lynch Syndrome", Peutz- Jeghers Syndrome, MUTYH Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
  6. Positive Shield test result within the previous 3 years

  7. History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)

  8. Known diagnosis of inflammatory bowel disease

  9. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)

  10. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent

  11. Known medical condition which, in the opinion of the Investigator, should preclude enrollment into the study

  12. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Enrolled Subjects

Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study.

Shield Blood Test for colo-rectal cancer Screening

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Performance measures of the Shield test will be assessed for the second testing interval
Tidsramme: 33-42 Months Post-Enrollment
  • Advanced Neoplasia Specificity
  • AA Sensitivity
  • CRC Sensitivity
  • PPV for: CRC, AA, and advanced neoplasia.
  • NPV for: CRC and advanced neoplasia
33-42 Months Post-Enrollment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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)

14. juli 2025

Primær fullføring (Antatt)

1. september 2030

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

11. mars 2025

Først innsendt som oppfylte QC-kriteriene

11. mars 2025

Først lagt ut (Faktiske)

17. mars 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

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. .

Abonnere