Osteopontin in Metastatic Breast Cancer Patients

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT04274504
Collaborator
(none)
119
1
58
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Osteopontin

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
119 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Osteopontin Level and Promoter Polymorphism in Egyptian Metastatic Breast Cancer Patients
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
patients

metatstatic breast

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.

Outcome Measures

Primary Outcome Measures

  1. 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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
31 Years to 74 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Oncology Center Mansoura Daqahliyah Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Principal Investigator: Mohamed A Elbaiomy, Mansoura university Oncology Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT04274504
Other Study ID Numbers:
  • IRB 2019035
First Posted:
Feb 18, 2020
Last Update Posted:
Feb 18, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2020