Clinical trial NCT03474016: Cell Free DNA and Its Integrity Using ALU Sequences as a Biomarker for Diagnosis of Breast Cancer
Official title: The Role of Circulating Cell-free DNA and Its Integrity Using ALU (247/115) bp Sequences as a Biomarker for Diagnosis of Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 116
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted on one hundred informed and consented female individuals (according to the guidelines of ethical committee of faculty of Medicine, Assuit University and South Egypt Cancer Institute.

Brief summary: Breast cancer (BC) is the most common cancer in women worldwide, and is the leading cause of death from cancer among women globally. Mammography is the standard method for early detection of BC in many countries, with over 1.3 million annually new diagnosed cases.In Egypt, breast cancer is the most common cancer in females accounting for 38.8% of all female cancers.

Detailed description: Breast cancer (BC) is the most common cancer in women worldwide, and is the leading cause of death from cancer among women globally. Mammography is the standard method for early detection of BC in many countries, with over 1.3 million annually new diagnosed cases.In Egypt, breast cancer is the most common cancer in females accounting for 38.8% of all female cancers. Whereas radiological screening programs have been successfully applied in detecting breast cancer in earlier stages, no valuable blood biomarkers have been yet identified for that purpose. However, false-positive recall rates vary according to age, breast density, and postmenopausal hormonal therapy, among other. For women with dense breasts, the accuracy of mammography is decreased. Circulating serum marker for monitoring of BC have been in development for several decades. Conventional tumor markers, such as cancer antigen 15-3 (CA15-3), carcinoembryonic antigen (CEA)), and circulating tumor cell count (CTC), are clinically available, however, their usefulness is mostly limited to patients with advanced and metastatic BC (MBC). Hence, there is a need for developing new biomarkers which can be used as valuable tools in identifying high risk patients, to predict disease prognosis and thus have an impact in patient management.Cell free DNA (cfDNA) are short fragments of nucleic acids present in the circulation. Multiple studies also have indicated elevated levels of cf DNA in breast cancer. The ALU(Arthrobacter luteus) sequences were chosen, as they are the most abundant and active repeated elements in the human genome, typically 300 nucleotides in length, accounting for more than 10% of the genome. DNA integrity was calculated as the ratio of (ALU247/ALU115). As the annealing sites of ALU115 are within the ALU247 annealing sites, thus the ratio of ALU247 to ALU115 is termed as DNA integrity. It characterizes the fragmentation pattern of circulating cell free DNA. The DNA integrity is "1" if template DNA is not truncated and "0" if DNA is completely truncated to fragments smaller than 247 bp (base pair). Thus it has been assessed for its diagnostic and prognostic potential role in breast cancer patients

Eligibility criteria: Inclusion Criteria:

* All patients enrolled before initiation of any treatment.

Exclusion Criteria:

* Any other malignant or benign tumors.
* Active inflammatory or autoimmune diseases.
* Renal or liver diseases.

Primary outcomes:
measure: Diagnostic values of cell free DNA using ALU (Arthrobacter luteus) sequence levels (247 bp (base pair), 115bp) and its integrity in peripheral blood of breast cancer patients as non invasive marker.
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
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