Identifying Tissue-of-origin in Transplant Patients and Patients with Malignancies. (cfDNA)

Identifying Tissue-of-origin and Gene Expression Program by Immunoprecipitation of Cell-free Nucleosomes in Transplant Patients and Patients with Malignancies.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignancies

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9112001
    • Hdassah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Kidney and liver transplant recipients

Description

Inclusion Criteria:

Kidney and liver transplant recipients Patients with malignant tumors

Exclusion Criteria:

Pregnant women Minors Incompetent Chronic background disease.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of liver function tests including ALT and AST levels after immunosuppression	Reduction of liver enzymes following immunosuppression treatment	Measurements of liver enzymes after diagnosis of acute rejection

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Study Chair: Tamar Hamburger, MRS, Gene Therapy Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 12, 2027

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: DNA; Liver cancer; gene expression
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 0030-19-HMO; Israel ministry of health (Other Identifier: Israel ministry of health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication
• IPD Sharing Time Frame: January 2028 for 7 years.
• IPD Sharing Access Criteria: After publication any one.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No