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Early Detection of de Novo Cancer in Liver Transplant Recipients

NCT05492617 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3628

Last updated 2022-08-08

No results posted yet for this study

Summary

Background The risk of cancer in liver transplant recipients is twice the cancer risk in the general population and de novo cancers are one of the leading causes of death after liver transplantation. The immunosuppressive medication, used to prevent organ rejection, is considered a key factor increasing the risk of de novo cancer.

Objectives I. Determine prevalence and incidence of de novo cancer in liver transplant recipients and build an algorithm to identify high-risk individuals II. Investigate if opportunistic viral infections (as a surrogate for over-immunosuppression) is associated with non-virus associated de novo cancers III. Investigate if cell free DNA fragmentation can be used to identify liver transplant recipients with de novo cancers and to identify cancer at an asymptomatic stage

Methods The study is in collaboration with all five Scandinavian liver transplant centers in ScandiaTransplant (Copenhagen, Oslo, Gothenburg, Stockholm and Helsinki) and includes all liver transplant recipients from the centers. Data on demographics, de novo cancer and risk factors are retrieved from electronic health records, cancer registries and the ScandiaTransplant database (n=3628). Blood samples to perform viral and cell free DNA fragmentation analyses are retrieved from the biobank at Rigshospitalet (n=932).

Implications The study includes a large cohort of liver transplant recipients from all of Scandinavia. With cancer as one of the primary causes of death in liver transplant recipients, new tools are needed to identify recipients with increased risk of developing de novo cancer. In particular, new tools allowing early diagnosis of de novo cancer enabling curative intended intervention. The study has potential to identify liver transplant recipients with increased risk of developing de novo cancer and reduce cancer related mortality.

Conditions

  • De Novo Cancer
  • Liver Transplant Disorder

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2020-12-31
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05492617 on ClinicalTrials.gov