Breast CancerNCT00539422
Role of Cytochrome P450 2D6 (CYP2D6) *4 Polymorphism,in Malignant Breast Diseases
An observational study of Breast Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of our study is to investigate the potential role of the CYP2D6*4 polymorphism in breast cancer and furthermore to assess the role of oxidative stress, antioxidant capacity and ferretin in pathogenesis of breast cancer in different CYP2D6*4 genotypes Read more about this study
- Who is it for?
- Ages 33 to 63 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pcr and serum markers for breast cancer
- How many people
- Not given
- Where
- 1 siteEgypt
- Study dates
- Jan 2006to Apr 2007
- 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 33 to 63 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- This study included 31 women admitted to the general surgery department, Mansoura University Hospital. group I consists of 15 women with benign breast lesion, group II composed of 16 women with cancer breast and 13 healthy women with matched age and clinically free were taken as a control group.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura Faculty of Medicine
Al Mansurah, Dakahlia Governorate, 35116
About this study
Official title: Role of Cytochrome P450 2D6 (CYP2D6) *4 Polymorphism, Oxidative Stress and Ferretin in Benign and Malignant Breast Diseases
The aim of our study is to investigate the potential role of the CYP2D6*4 polymorphism in breast cancer and furthermore to assess the role of oxidative stress, antioxidant capacity and ferretin in pathogenesis of breast cancer in different CYP2D6*4 genotypes
Read the detailed description
Breast cancer is the most common malignancy among women and the second highest cause of cancer death. Nevertheless most of the breast cancer is sporadic with no family history of the disease, Enhanced CYP2D6 activity has been related to malignancies of the bladder, liver, pharynx, and stomach and, especially, to cigarette-smoking-induced lung cancer. Data support that increased formation of reactive oxygen species (ROS) may play an important role in carcinogenesis Numerous in vitro experiments show that ROS damages DNA, inducing premutagenic modifications of nucleotides and promoting oxidation of proteins and lipid per oxidation The aim of our study is to investigate the potential role of the CYP2D6*4 polymorphism in breast cancer and furthermore to assess the role of oxidative stress, antioxidant capacity and ferretin in pathogenesis of breast cancer in different CYP2D6*4 genotypes.patients and methods : This study included 31 women admitted to the general surgery department, Mansoura University Hospital. group I consists of 15 women with benign breast lesion, group II composed of 16 women with cancer breast and 13 healthy women with matched age and clinically free were taken as a control group. DNA extraction and genotyping of cytochrome P450-2D6*4 gene using conventional PCR followed by restriction enzyme (Mva1) digestion. Separated plasma was used for measurement of plasma malondialdehyde(MDA)concentration, total plasma antioxidant capacity and plasma ferretin level.Results homozygous genotype of 2D6*4 represent 56.25 %( 9/16) of breast cancer group with lower wild type (31.25%-5/16), while it represent 33.3 %( 5/15) of begnine breast lesion group and 15.3(2/13) of the control group. Where the wild type represent the majority of cases (61.15%-8/13) in the control group and 46.6%-7/15) in the begnine breast lesion group.
statistically significant increase in plasma ferretin and MDA mean levels in breast cancer group than begnine breast lesion and the control groups .Also, there is an increase in plasma total antioxidant activity in breast cancer group than the control group with nonstatistical difference between the breast cancer and the benign breast lesion groups .
Conclusion CYP2D6*4 genotype polymorphism interacting with plasma malondialdehyde (MDA) oxidative stress and plasma ferretin level may have a role in the pathogenesis of breast cancer
- Conditions
- Breast Cancer
- Being tested
- pcr and serum markers for breast cancer
- Keywords
- breast cancer, cytochrome 450, CYP2D6*4, Ferritin, oxidative stress, cancer, cancer breast
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pcr and serum markers for breast cancerGenetic
DNA extraction and genotyping of cytochrome P450-2D6*4 gene using conventional PCR followed by restriction enzyme (Mva1) digestion. Separated plasma was used for measurement of plasma malondialdehyde(MDA)concentration, total plasma antioxidant capacity and plasma ferretin level.
| Study group | Role | What they receive |
|---|---|---|
| I | group I of 15 women with benign breast lesion Receives: Genetic: pcr and serum markers for breast cancer | |
| II | group II of 16 women with breast cancer Receives: Genetic: pcr and serum markers for breast cancer | |
| III | 13 women were taken as a control group Receives: Genetic: pcr and serum markers for breast cancer |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startJan 2006
- Study completionApr 2007
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 Mansoura 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
- Case-control
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- wagih m ghnnam, Principal investigator, mansoura faculty of medicine general surgery departmentAymen z El Samanoudy, Study director, mansoura faculty of medicine biochemistry department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539422
- Sponsor's protocol ID
- Role of cytochrome P450 2D6
- Status last verified
- Oct 2007
- First submitted
- 3 Oct 2007
- Last updated
- 4 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cytochrome P450 2D6 (CYP2D6) *4 Polymorphism, Oxidative Stress and Ferretin in Benign and Malignant Breast Diseases
- ClinicalTrials.gov ID
- NCT00539422
- Acronym / sponsor ID
- Role of cytochrome P450 2D6
- Conditions
- Breast Cancer
- Keywords
- breast cancer, cytochrome 450, CYP2D6*4, Ferritin, oxidative stress, cancer, cancer breast
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 4 Oct 2007 (estimated)
- 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.
The aim of our study is to investigate the potential role of the CYP2D6*4 polymorphism in breast cancer and furthermore to assess the role of oxidative stress, antioxidant capacity and ferretin in pathogenesis of breast cancer in different CYP2D6*4 genotypes
Detailed description
Breast cancer is the most common malignancy among women and the second highest cause of cancer death. Nevertheless most of the breast cancer is sporadic with no family history of the disease, Enhanced CYP2D6 activity has been related to malignancies of the bladder, liver, pharynx, and stomach and, especially, to cigarette-smoking-induced lung cancer. Data support that increased formation of reactive oxygen species (ROS) may play an important role in carcinogenesis Numerous in vitro experiments show that ROS damages DNA, inducing premutagenic modifications of nucleotides and promoting oxidation of proteins and lipid per oxidation The aim of our study is to investigate the potential role of the CYP2D6*4 polymorphism in breast cancer and furthermore to assess the role of oxidative stress, antioxidant capacity and ferretin in pathogenesis of breast cancer in different CYP2D6*4 genotypes.patients and methods : This study included 31 women admitted to the general surgery department, Mansoura University Hospital. group I consists of 15 women with benign breast lesion, group II composed of 16 women with cancer breast and 13 healthy women with matched age and clinically free were taken as a control group. DNA extraction and genotyping of cytochrome P450-2D6*4 gene using conventional PCR followed by restriction enzyme (Mva1) digestion. Separated plasma was used for measurement of plasma malondialdehyde(MDA)concentration, total plasma antioxidant capacity and plasma ferretin level.Results homozygous genotype of 2D6*4 represent 56.25 %( 9/16) of breast cancer group with lower wild type (31.25%-5/16), while it represent 33.3 %( 5/15) of begnine breast lesion group and 15.3(2/13) of the control group. Where the wild type represent the majority of cases (61.15%-8/13) in the control group and 46.6%-7/15) in the begnine breast lesion group.
statistically significant increase in plasma ferretin and MDA mean levels in breast cancer group than begnine breast lesion and the control groups .Also, there is an increase in plasma total antioxidant activity in breast cancer group than the control group with nonstatistical difference between the breast cancer and the benign breast lesion groups .
Conclusion CYP2D6*4 genotype polymorphism interacting with plasma malondialdehyde (MDA) oxidative stress and plasma ferretin level may have a role in the pathogenesis of breast cancer
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | – | Genetic: pcr and serum markers for breast cancergroup I of 15 women with benign breast lesion |
| II | – | Genetic: pcr and serum markers for breast cancergroup II of 16 women with breast cancer |
| III | – | Genetic: pcr and serum markers for breast cancer13 women were taken as a control group |
Who may qualify
- Ages
- 33 to 63 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This study included 31 women admitted to the general surgery department, Mansoura University Hospital. group I consists of 15 women with benign breast lesion, group II composed of 16 women with cancer breast and 13 healthy women with matched age and clinically free were taken as a control group.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| pcr and serum markers for breast cancerDNA extraction and genotyping of cytochrome P450-2D6*4 gene using conventional PCR followed by restriction enzyme (Mva1) digestion. Separated plasma was used for measurement of plasma malondialdehyde(MDA)concentration, total plasma antioxidant capacity and plasma ferretin level. | Genetic | I, II, III |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2007.
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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.
wagih m ghnnam principal investigator
mansoura faculty of medicine general surgery department
Aymen z El Samanoudy study director
mansoura faculty of medicine biochemistry department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mansoura University at 1 site in Egypt.
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 0 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: finished, as of the sponsor's last update on 4 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 4 Oct 2007.