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

NCT06703853 | Active Not Recruiting

• 2 other identifiers: 0030-19-HMOIsrael ministry of health
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignancies

Keywords

gene expression; DNA; Liver cancer

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney and liver transplant recipients

You may qualify if:

• Kidney and liver transplant recipients Patients with malignant tumors

You may not qualify if:

• Pregnant women Minors Incompetent Chronic background disease.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hdassah Hospital

Jerusalem, 9112001, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples for cfDNA

MeSH Terms

Conditions

Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Tamar Hamburger, MRS

  Gene Therapy Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 25, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 12, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 2028 for 7 years.
• Access Criteria: After publication any one.

Locations

IL (1)