Osteopontin in Metastatic Breast Cancer Patients

Survival, Prosthesis Clinical Trial

Official title:

Osteopontin Level and Promoter Polymorphism in Egyptian Metastatic Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04274504
• Other study ID #: IRB 2019035
• Status: Completed
• Start date: January 2015
• Est. completion date: November 2019

Study information

• Verified date: February 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 31 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Prosthesis Failure
• Survival, Prosthesis

Intervention

Diagnostic Test:
• Osteopontin
Serum osteopontin (OPN) was measured by ELIZA and osteopontin gene mutation was analyzed by sequencing and correlated with clinicopathological criteria, response, PFS and OS.

Locations

Country	Name	City	State
Egypt	Mansoura University Oncology Center	Mansoura	Daqahliyah

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years