Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.
NCT ID: NCT04081194
Last Updated: 2019-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15 participants
OBSERVATIONAL
2016-10-01
2019-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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case group, Melanoma Patients
15 patients of with Melanoma, Age between 40 and 90 years.
-Withdrawal of Blood sample, Isolation of Exosomes:
1. Bradford protein assay And Qubit protein assay.
2. Bioanalyzer.
3. Real time PCR.
No interventions assigned to this group
control group
10 Persons without Melanoma, age \> 40 years
-Withdrawal of Blood sample, Isolation of Exosomes:
1. Bradford protein assay And Qubit protein assay.
2. Bioanalyzer.
3. Real time PCR.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
90 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Sara Alameldin
Assisstent Lecturer
Principal Investigators
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Hesham A Abdel-Baset, Prof.
Role: STUDY_DIRECTOR
Assiut University- Faculty of Medicine- Clinical Pathology dept.
Locations
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Assiut University Hospitals- Faculty of Medicine
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Sara Alameldin 20.06.2016
Identifier Type: -
Identifier Source: org_study_id
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