Clinical trial NCT04081194: Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.
Official title: Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: New Tumor Diagnostics From Human Plasma Samples
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study group: 15 Patients control Group: 10 Persons

Brief summary: Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.

Detailed description: Cell free circulating free nucleic acids is new substrates for laboratory diagnostics in a number of medical areas including oncology, transfusion medicine, gynecology/obstetrics, inflammatory and autoimmune diseases etc.There are various qualities of cell free nucleic acids. In oncology, it has been shown that the early detection of cell free nucleic acids originating from the tumour preceeds the diagnostic detection of clinical relapse as done by imaging techniques or clinical symptoms by 6-8- months.

Exosomes are small, lipid bilayer membrane vesicles (30-100 nm) that are released from all cell types into the extracellular space. These tiny membrane vesicles transmit EV-mediated signals by proteins, lipids, nucleic acids and sugars, and the unique molecular pattern of this package direct the type of extracellular signal to be transmitted to target cells. Interest in exosomes range from their mode of action and various functions in the body to more practical applications such as development of biomarkers based on analysis of their RNA and protein content and their use in clinical diagnostics. It was proposed that micro RNAs are transferred through exosomes to recipient cells and can there mediate repression of their mRNA targets.

The use of highly expensive targeted therapies (e.g. tyrosine kinase inhibitors or PARP inhibitors) may become obsolete during therapy due to changes in the mutational molecular profile of the malignant tumour. Indeed, if early detection of cell free nucleic acids suggest therapy failure, new stratification of the patient and changed therapy modalities may be possible in the future, thus helping to prolong overall survival of tumour patients.

Aims of the Research:

* To isolate exosomes as a stable source of cell free nucleic acids.
* To perform protein profiling on the isolated exosomes.
* To isolate nucleic acids from exosomes for analysis.
* To define and develop standards and protocols for cell free nucleic acids analysis particularly regarding epigenetic alterations with emphasis on DNA methylation.
* Optimizing of pre-analytical process to improve the pre-analytical aspects of assays.
* To test the stability of methylated compared to non-methylated circulating DNA under various pre-analytical conditions.

Eligibility criteria: Inclusion Criteria:

* patients with Melanoma

Exclusion Criteria:

* patients with other types of malignancies

Primary outcomes:
measure: Isolation of Exosomes as a stable source of nucleic acid as an early Detection Method to diagnose Melanoma.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals- Faculty of Medicine
Study officials:
affiliation: Assiut University- Faculty of Medicine- Clinical Pathology dept.
name: Hesham A Abdel-Baset, Prof.
role: STUDY_DIRECTOR
References: