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Viral Reactivation and Skin Cancer

11. juli 2016 oppdatert av: University of Zurich

Association of Viral Reactivation and Skin Cancer in Organ Transplant Recipients

Several studies show that the incidence of skin cancer parallels the length and depth of immunosuppression. This study will analyze the correlation of viral reactivation and skin cancer in organ transplant recipients.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Squamous Cell Carcinoma of the skin (SCC) affects people in high numbers worldwide. While a yearly increase of over 2 million patients, who develop cancer, is recorded, organ transplant recipients (OTR) have a 60- to 100-fold higher risk of developing skin cancer. In OTRs, skin cancer is the most frequent tumor that appears, whereas 95% are nonmelanoma skin cancer cells: squamous cells or basal cell carcinomas. All OTRs need to be treated lifelong with immunosuppressants in order to prevent the rejection of the transplanted organ. However, this immunosuppressive treatment leads to a decrease of immunity, and therefore, cancer cells are able to proliferate easier.

Several studies show that the incidence of skin cancer parallels the length and depth of immunosuppression. The appearance of CD4 in OTRs with cutaneous carcinomas is significantly lower compared to those without skin lesions. Various findings have shown a positive correlation of the period of exposure to immunosuppressants and the risk of skin cancer. However, little is known about the dose or the type of drug is responsible for skin cancer. The uptake of three immunosuppressive medicaments compared to the uptake of two results in a 3-fold increased risk of developing cancer. The consequence of the immunosuppressive therapy is reversible; patients who stop immunosuppressive treatment often show a decrease in skin cancer. The highest risk for organ rejection is during the first three months after transplantation. Therefore, an increased dose of immunosuppressors is used during this time.

In addition to cancer, a high increase of viral infections and reactivations is seen in OTRs. Over 90% of the population carries herpesviruses. The risk of viral infection and reactivation is much higher in OTRs. While inducing a decrease in immunosurveillance, herpesvirus can spread easier.

Herpesvirus infections due to the eight human herpes viruses (HHV) are more frequent by immunosuppression in OTRs. Once a patient is infected with one of the human herpesvirus types (Herpes simplex viruses 1 and 2, varicella-zoster virus, Epstein-Barr virus, human cytomegalovirus, human herpesvirus 6 and 7, or Kaposi's sarcoma-associated herpesvirus), the virus is able to establish a latent, non-productive infection and maintains the capacity for a life-long reactivation. Due to the decrease of immunity, OTRs are highly susceptible to activate this latent herpesviral infection, which is a critical aspect of the immunosuppressive treatment. The risk of the reactivation of Cytomegalovirus and Epstein-Barr virus in OTRs is much higher compared to the general population.

Taking the above discussed findings together, the investigators hypothesize that viral infections and reactivations correlate positively with skin cancer in OTRs. Furthermore, the investigators think that viral reactivation and infection can be used as a marker for a later incidence of skin cancer. While virus infections and reactivations appear early, OTRs become affected by SCC in the early and in the late period after the transplantation. The investigators thus aim to analyze existing data from the STCS and its nested studies to test these hypotheses: To assess the correlation of viral replication and skin cancer in organ transplant recipients and to assess viral replication as predictor for skin cancer. The investigators are interested in all data available from other studies of the STCS and to divide all organ transplant recipients e.g. for CMV in four groups: no replication, a larger group who show asymptomatic viral replication, some of them with viral syndrome and the ones with proven disease.

Studietype

Observasjonsmessig

Registrering (Faktiske)

1200

Kontakter og plasseringer

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

Studiesteder

      • Zurich, Sveits, 8091
        • University Hospital Zürich, Dermatology

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

organ transplant recipients within the STCS.

Beskrivelse

Inclusion Criteria:

  • oral and written consent to inclusion
  • recipient of solid organ transplant

Exclusion Criteria:

  • withdrawal of inform consent

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
OTR and viral reactivation
Organ transplant recipients with and without viral reactivation and skin cancer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The correlation of skin cancer with viral reactivation in organ transplant recipients
Tidsramme: 10 years
10 years

Sekundære resultatmål

Resultatmål
Tidsramme
The association of viral reactivation and infection in the first year and skin cancer in the following years. Can one be used as a marker for the other one?
Tidsramme: 10 years
10 years

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Günther Hofbauer, Prof. MD, University Hospital Zürich, Dermatology

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

1. januar 2008

Primær fullføring (Faktiske)

1. januar 2016

Studiet fullført (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først innsendt

17. mars 2015

Først innsendt som oppfylte QC-kriteriene

20. mars 2015

Først lagt ut (Anslag)

23. mars 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

shared with Swiss Transplant Cohort Study. Future projects can obtain data after having a project request approved.

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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