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

November 21, 2024 updated by: Eithan Galun, Hadassah Medical Organization

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 9112001
        • Hdassah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement of liver function tests including ALT and AST levels after immunosuppression
Time Frame: Measurements of liver enzymes after diagnosis of acute rejection
Reduction of liver enzymes following immunosuppression treatment
Measurements of liver enzymes after diagnosis of acute rejection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hadassah Medical Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tamar Hamburger, MRS, Gene Therapy Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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