Breast CancerNCT03474016
Cell Free DNA and Its Integrity Using ALU Sequences as a Biomarker for Diagnosis of Breast Cancer
An observational study of Breast Cancer, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All patients enrolled before initiation of any treatment.
Who cannot join
- Any other malignant or benign tumors.
- Active inflammatory or autoimmune diseases.
- Renal or liver diseases.
About this study
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
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.
Read the 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
- Being tested
- Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography-Histopathological examination of breast mass specimens- polymerase chain reactionDiagnostic test
Mammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction
| Study group | Role | What they receive |
|---|---|---|
| Patients with early breast cancer(30) | Not described Receives: Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction | |
| Patients with advanced breast cancer(30) | Not described Receives: Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction | |
| Patients with benign breast diseases(20) | Not described Receives: Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction | |
| Apparently healthy females as a control group(36) | Not described Receives: Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study startJul 2018 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mostafa Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474016
- Sponsor's protocol ID
- CFDAIIUASABFDOBC
- Status last verified
- May 2018
- First submitted
- 16 Mar 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03474016
- Acronym / sponsor ID
- CFDAIIUASABFDOBC
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with early breast cancer(30) | – | Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction |
| Patients with advanced breast cancer(30) | – | Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction |
| Patients with benign breast diseases(20) | – | Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction |
| Apparently healthy females as a control group(36) | – | Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients enrolled before initiation of any treatment.
Key exclusion criteria (3 listed)
- Any other malignant or benign tumors.
- Active inflammatory or autoimmune diseases.
- Renal or liver diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mammography-Histopathological examination of breast mass specimens- polymerase chain reactionMammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction | Diagnostic test | Apparently healthy females as a control group(36), Patients with advanced breast cancer(30), Patients with benign breast diseases(20), Patients with early breast cancer(30) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.