An observational study in Malignancies, sponsored by Hadassah Medical Organization. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Hadassah Medical Organization · Observational
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.
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 1,000 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Hadassah Medical Organization is the lead sponsor of 674 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Kidney and liver transplant recipients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Kidney and liver transplant recipients Patients with malignant tumors
Exclusion Criteria:
Pregnant women Minors Incompetent Chronic background disease.
Improvement of liver function tests including ALT and AST levels after immunosuppression
Reduction of liver enzymes following immunosuppression treatment
Time frame: Measurements of liver enzymes after diagnosis of acute rejection
Plan to share: Yes — Publication
Supporting information: Study protocol
Time frame: January 2028 for 7 years.
Access criteria: After publication any one.
Data sharing details ↗ · www.eithangalun.com
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Nov 2027, 39 months after the start.
Of 792 non-industry observational studies under Neoplasms, half reached primary completion within 102 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 352. This study's planned 39 months is below that.
Counting every sponsor, half of 884 studies reached it within 80 months; a quarter within 32 and three quarters within 318.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hadassah Medical Organization →