Survival, ProsthesisNCT04274504
Osteopontin in Metastatic Breast Cancer Patients
An observational study of Survival, Prosthesis, run by Mansoura University at 1 site in Egypt.
Trial summary
OPN plays an important role in various aspects of malignancy, particularly those involved in tissue invasion and metastasis, and OPN levels have been associated with aggressive¬ness in several cancer types, including breast cancer. Read more about this study
- Who is it for?
- Ages 31 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Survival, Prosthesis
- What is being tested?
- Osteopontin
- How many people
- 119 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Nov 2019
- How long will I take part?
- 2 Years
- 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 31 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Denovo Metastatic breast
Who may be able to join
- de novo metastatic breast cancer patients recruited from Oncology center Mansoura University and clinical oncology department, Mansoura University Hospital All included patients were presented with disseminated visceral +/- bone metastasis (visceral crisis)
Who cannot join
- brain metastasis was excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Oncology Center
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Osteopontin Level and Promoter Polymorphism in Egyptian Metastatic Breast Cancer Patients
OPN plays an important role in various aspects of malignancy, particularly those involved in tissue invasion and metastasis, and OPN levels have been associated with aggressive¬ness in several cancer types, including breast cancer. Tumor response to treatment is a predictor of prognosis and overall survival for cancer patient population the investigators assigned osteopontin as potential contributors in breast cancer.
Read the detailed description
Analysis of polymorphisms in the OPN regulatory region:
The PCR amplification of the promoter regulatory region from the extracted DNA by using the following primers -3 (forward primer 5" -CAA GCT ACT GCA TAC TCG AAA TCA CA-3" ; reverse primer 5" - ACA ACC AAG CCC TCC CAG AAT TTA-3" ). PCR was performed using 50 ng DNA as a template under the following conditions: 95°C for 10 min, then 36 cycles of 94°C for 30 s, an annealing temperature for 60 s, and 72°C for 60 s, with a final extension at 72°C for 15 min. After affinity membrane purification using the QIAquick Gel Extraction kit (Qiagen, Carlsbad, CA, USA), the PCR products were subjected to cycle sequencing with the respective forward and reverse primer using an automated ABI 310 DNA sequencer.
Measurement of serum level of osteopontin:
OPN level were measured using Enzyme linked immnosorbent (ELISA) Kit supplied by IBL (Immuno-Biological laboratories Co. Ltd., Japan). 30 normal females were conducted with matched age with a median osteopontine serum level of 15 so, this level was assigned as a cut off value.
Pretreatment serum level and polymorphism of oteopontine was correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS.
- Conditions
- Survival, Prosthesis
- Being tested
- Osteopontin
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteopontinDiagnostic test
Serum osteopontin (OPN) was measured by ELIZA and osteopontin gene mutation was analyzed by sequencing and correlated with clinicopathological criteria, response, PFS and OS.
| Study group | Role | What they receive |
|---|---|---|
| patients | metatstatic breast Receives: Diagnostic Test: Osteopontin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Both pretreatment serum level of oteopontin and gene mutation were correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS.
Serum osteopontin (OPN) was measured by ELIZA and osteopontin gene mutation was analyzed by sequencing and correlated with clinicopathological criteria, response, PFS and OS.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study startJan 2015
- Primary completionOct 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival, ProsthesisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed A Elbaiomy, Principal investigator, Mansoura university Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274504
- Sponsor's protocol ID
- IRB 2019035
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopontin Level and Promoter Polymorphism in Egyptian Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04274504
- Acronym / sponsor ID
- IRB 2019035
- Conditions
- Survival, Prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 18 Feb 2020 (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.
OPN plays an important role in various aspects of malignancy, particularly those involved in tissue invasion and metastasis, and OPN levels have been associated with aggressive¬ness in several cancer types, including breast cancer. Tumor response to treatment is a predictor of prognosis and overall survival for cancer patient population the investigators assigned osteopontin as potential contributors in breast cancer.
Detailed description
Analysis of polymorphisms in the OPN regulatory region:
The PCR amplification of the promoter regulatory region from the extracted DNA by using the following primers -3 (forward primer 5" -CAA GCT ACT GCA TAC TCG AAA TCA CA-3" ; reverse primer 5" - ACA ACC AAG CCC TCC CAG AAT TTA-3" ). PCR was performed using 50 ng DNA as a template under the following conditions: 95°C for 10 min, then 36 cycles of 94°C for 30 s, an annealing temperature for 60 s, and 72°C for 60 s, with a final extension at 72°C for 15 min. After affinity membrane purification using the QIAquick Gel Extraction kit (Qiagen, Carlsbad, CA, USA), the PCR products were subjected to cycle sequencing with the respective forward and reverse primer using an automated ABI 310 DNA sequencer.
Measurement of serum level of osteopontin:
OPN level were measured using Enzyme linked immnosorbent (ELISA) Kit supplied by IBL (Immuno-Biological laboratories Co. Ltd., Japan). 30 normal females were conducted with matched age with a median osteopontine serum level of 15 so, this level was assigned as a cut off value.
Pretreatment serum level and polymorphism of oteopontine was correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Diagnostic Test: Osteopontinmetatstatic breast |
Who may qualify
- Ages
- 31 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Denovo Metastatic breast
Key inclusion criteria (1 listed)
- de novo metastatic breast cancer patients recruited from Oncology center Mansoura University and clinical oncology department, Mansoura University Hospital All included patients were presented with disseminated visceral +/- bone metastasis (visceral crisis)
Key exclusion criteria (1 listed)
- brain metastasis was excluded
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 |
|---|---|---|
| OsteopontinSerum osteopontin (OPN) was measured by ELIZA and osteopontin gene mutation was analyzed by sequencing and correlated with clinicopathological criteria, response, PFS and OS. | Diagnostic test | patients |
Primary outcome
Both pretreatment serum level of oteopontin and gene mutation were correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS.
Time frame: 2 years
Serum osteopontin (OPN) was measured by ELIZA and osteopontin gene mutation was analyzed by sequencing and correlated with clinicopathological criteria, response, PFS and OS.
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 18 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Mohamed A Elbaiomy principal investigator
Mansoura university Oncology Center
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 Survival, Prosthesis, 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 1 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 18 Feb 2020. 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.
What does the primary outcome measure?
Both pretreatment serum level of oteopontin and gene mutation were correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS. (time frame: 2 years). 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 18 Feb 2020.