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

May 17, 2018 updated by: Fatma Mostafa Mohamed, Assiut University

The Role of Circulating Cell-free DNA and Its Integrity Using ALU (247/115) bp Sequences as a Biomarker for Diagnosis of Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with early breast cancer(30)
Diagnostic test: 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
Patients with advanced breast cancer(30)
Diagnostic test: 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
Patients with benign breast diseases(20)
Diagnostic test: 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
Apparently healthy females as a control group(36)
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFDAIIUASABFDOBC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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