The main objective of this study is to identify changes in DNA methylation of CD3+ T cells associated with cSCC after organ transplantation.
ID
Source
Brief title
Condition
- Other condition
- Skin neoplasms malignant and unspecified
Synonym
Health condition
orgaantransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the difference in DNA methylation in CD3+ T
cells between organ transplant recipients who developed cSCC and organ
recipients who did not develop a malignancy.
Secondary outcome
not applicable
Background summary
The most common malignancy after solid organ transplantation is cutaneous
squamous cell carcinoma (cSCC). Compared to the general population this
recurrent skin tumour is 200 times more common in transplant recipients and
grows and metastasizes more rapidly leading to increased morbidity and
mortality. The chronic use of non-specific immunosuppressive medication after
transplantation suppresses T cell functions, including T cell reactivity
against donor antigen, but also disrupts antiviral and antitumour
immunosurveillance by T cells. Aberrant DNA methylation profiles are more and
more associated with diseases, specifically with the development and
progression of malignancies. Here we hypothesize that the DNA methylation
profile of CD3+ T cells in blood is significantly different in organ transplant
recipients who developed a cSCC compared to organ transplant recipients who did
not develop a malignancy.
Study objective
The main objective of this study is to identify changes in DNA methylation of
CD3+ T cells associated with cSCC after organ transplantation.
Study design
This is an investigator-driven, observational (case-control) study comparing
DNA methylation profiles of CD3+ T cells from organ transplant recipients with
and without cSCC.
Study burden and risks
During routinely follow-up of transplant recipients blood is drawn to measure
trough levels of the immunosuppressive medication and at the same moment blood
will be drawn for this study (5 heparin tubes of 6 ml and 1 coaggulation tube
of 6 ml = 36ml blood). There are no risks involved in participation of the
study. The included patients do not directly benefit from participation, though
they could contribute to identification of patients at risk for the development
of a post-transplant cSCC in the future.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Patients with (cases) compared to patients without (controls) cutaneous squamous cel carcinoma after their first organ transplantation
Exclusion criteria
Previous transplantation (either solid or non-solid organ transplantation)
History and presence of other malignancies (including skin malignancies before transplantation)
Under 18 years of age
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54386.078.15 |