Clinical trial NCT06703853: Identifying Tissue-of-origin in Transplant Patients and Patients with Malignancies.
Official title: Identifying Tissue-of-origin and Gene Expression Program by Immunoprecipitation of Cell-free Nucleosomes in Transplant Patients and Patients with Malignancies.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Malignancies
Keywords: gene expression
DNA
Liver cancer
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney and liver transplant recipients

Brief summary: the investigators are developing a method for diagnosing cell death in the body using blood and urine tests. The test is based on two well-known phenomena in biology. First, when cells in the body die, short fragments of their DNA, about 150 bases long, find their way into the bloodstream for a short period of time of about fifteen minutes to an hour, before being eliminated in the liver and kidney. The details of this process are not fully known, but it is clear that the phenomenon exists. Already today, this phenomenon is widely used clinically for prenatal diagnosis of chromosomal aberrations in the DNA of the fetus that is found in large quantities in the mother's blood. Liquid biopsies from cancer have already been developed, based on the identification of somatic mutations originating from a cancerous tumor in the free DNA found in the serum or plasma. In the case of cancer, liquid biopsies may be a convenient way to monitor the genetic evolution of the tumor, response to treatments, and more. This approach of detecting cell death using free DNA in the bloodstream has a severe limitation when it comes to the death of cells whose genome is not different from the genome of the other tissues in the body, and therefore the DNA cannot be associated with the tissue of origin based on sequence analysis.

Detailed description: The duration of the sample collection period is estimated to be five years. Work in the laboratory will continue for another 3 years. The laboratory work will be carried out in the laboratories of Prof. Eithan Galun at Hadassah Ein Kerem and Prof. Nir Friedman at the Hebrew University of Givat Ram. Access will be given to Prof. Galun and his team. Since genetic variation is not tested in this study, there is no fear of revealing the subject's personal genetic information. In this study we use an identified sample, on which identifying details for the participant are indicated, for example: name, social security number or code number that can be given to the sample. The identified information and the information that will be extracted from the sample will be saved in coded excel sheets. In this way, only authorized researchers and research staff will be allowed access. The samples will be preserved as coded identified samples in the laboratory of Prof. Eithan Galun, Hadassah Ein Kerem, Jerusalem in a freezer in a locked room with limited access to researchers and the authorized research team only, and also, in the laboratory of Prof. Nir Friedman, the Hebrew University of Givat Ram, Jerusalem under similar conditions with access to the research team only. the investigators also ask the liver and kidney transplant recipients to collect a urine sample, with the thought that it might be possible to save a blood test and be satisfied with a urine sample.

Eligibility criteria: Inclusion Criteria:

Kidney and liver transplant recipients Patients with malignant tumors

Exclusion Criteria:

Pregnant women Minors Incompetent Chronic background disease.

Primary outcomes:
measure: Improvement of liver function tests including ALT and AST levels after immunosuppression
timeFrame: Measurements of liver enzymes after diagnosis of acute rejection
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hdassah Hospital
Study officials:
affiliation: Gene Therapy Institute
name: Tamar Hamburger, MRS
role: STUDY_CHAIR
References: