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Status unknownNCT04081194Updated Sep 17, 2019

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

An observational study in New Tumor Diagnostics From Human Plasma Samples, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-17.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
15
Ages
50 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • New Tumor Diagnostics From Human Plasma Samples
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Study group: 15 Patients control Group: 10 Persons

Inclusion criteria

  • patients with Melanoma

Exclusion criteria

Exclusion Criteria:

  • patients with other types of malignancies
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

  • 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.

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What researchers measure

Primary outcomes

  1. Isolation of Exosomes as a stable source of nucleic acid as an early Detection Method to diagnose Melanoma.

    Real time PCR for detecting the presence of Melanoma relevant nucleic acids isolated of Exososmes.

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Assiut University Hospitals- Faculty of Medicine
    Assiut, 71111, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04081194
Lead sponsor
Assiut University
Responsible party
Sara Alameldin (Assisstent Lecturer, Assiut University) — Principal investigator
First posted
Sep 9, 2019
Start date
Oct 1, 2016
Primary completion
Nov 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Sep 17, 2019

Study contacts

Sara Alameldin, Dr
Contact
dr.saraalameldin@aun.edu.eg
+201007538845 -- +491577242714
Hesham A Abdel-Baset, Prof.
study director · Assiut University- Faculty of Medicine- Clinical Pathology dept.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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