Osteopontin in Metastatic Breast Cancer Patients

NCT ID: NCT04274504

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-11-30

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients

metatstatic breast

Osteopontin

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed A Elbaiomy

Role: PRINCIPAL_INVESTIGATOR

Mansoura university Oncology Center

Locations

Mansoura University Oncology Center

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB 2019035

Identifier Type: -

Identifier Source: org_study_id