Cell Free DNA and Its Integrity Using ALU Sequences as a Biomarker for Diagnosis of Breast Cancer

NCT ID: NCT03474016

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2020-07-31

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Patients with early breast cancer(30)

Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Intervention Type: DIAGNOSTIC_TEST

Mammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction

Patients with advanced breast cancer(30)

Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Intervention Type: DIAGNOSTIC_TEST

Mammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction

Patients with benign breast diseases(20)

Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Intervention Type: DIAGNOSTIC_TEST

Mammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction

Apparently healthy females as a control group(36)

Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Intervention Type: DIAGNOSTIC_TEST

Mammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction

Interventions

Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Mammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Mostafa Mohamed

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CFDAIIUASABFDOBC

Identifier Type: -

Identifier Source: org_study_id