- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04274504
Osteopontin in Metastatic Breast Cancer Patients
Osteopontin Level and Promoter Polymorphism in Egyptian Metastatic Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Daqahliyah
-
Mansoura, Daqahliyah, Egypt, 35516
- Mansoura University Oncology Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- brain metastasis was excluded
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients
metatstatic breast
|
Serum osteopontin (OPN) was measured by ELIZA and osteopontin gene mutation was analyzed by sequencing and correlated with clinicopathological criteria, response, PFS and OS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed A Elbaiomy, Mansoura University Oncology Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 2019035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Survival, Prosthesis
-
Technical University of MunichUnknown
-
Cukurova UniversityCompletedSurvival, Prosthesis | Clinical Acceptability, ProsthesisTurkey
-
Medacta International SARecruiting
-
Susanne ScherrerITI FoundationCompleted
-
Malo ClinicInvibio LtdEnrolling by invitation
-
Malo ClinicInvibio LtdEnrolling by invitationProsthesis SurvivalPortugal
-
Malo ClinicInvibio LtdActive, not recruiting
-
Istituto Ortopedico RizzoliCompleted
-
Cairo UniversityCompleted
-
Malo ClinicInvibio LtdEnrolling by invitationProsthesis SurvivalPortugal
Clinical Trials on Osteopontin
-
Assiut UniversityUnknownDiabetic Nephropathies | Vascular CalcificationEgypt
-
Biostime, Inc.University of California, Davis; University of Illinois at Urbana-Champaign; Children... and other collaboratorsUnknownGrowth | Health | Immune FunctionsChina
-
Eskisehir Osmangazi UniversityCompleted
-
Peking Union Medical College HospitalChengdu Yunke Pharmaceutical Co., Ltd.CompletedArthritis, PsoriaticChina
-
Renato Correa Viana CasarinCompleted