Partial PTEN Deletion in Breast Cancer

October 27, 2021 updated by: Fatma Refaat Ibrahim Ismail, Assiut University

Partial PTEN Deletion and Its Relation to Clinicopathological Characteristics in Breast Cancer Patients

  • Detection of chromosome 10q23 deletion including PTEN locus in breast cancer patients.
  • Correlation between PTEN deletion and clinicopathological characteristics in breast cancer patients.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Breast cancer is the most common carcinoma detected in women, accounting for about one fifth of new cancer cases in females. In Egypt breast cancer is the most common malignancy in women, accounting for 38,8% of cancers in this population, with the estimated number of breast cancer cases nearly 22700 in 2020 and forecasted to be approximately 46000 in 2050. Surgical removal of the cancer represents the standard of care followed by radiation and adjuvant therapy in patients considered to be at particular risk for systemic disease. Estimation of prognosis is of vital importance for tailoring adjuvant therapy in individual breast cancer patients. Conventional pathological parameters such as histological grade, tumor size and presence of lymph node metastasis are not accurate enough to select subsets of patients who are at sufficiently low risk of progression to be spared extensive adjuvant therapy without compromising the prognosis. Much hope is placed on cytogenetic features analysis which might help to improve prediction of patient prognosis.

Fluorescence in situ hybridization (FISH) is a molecular cytogenetic technique that enables the detection of genetic abnormalities such as gene amplification, deletions, and chromosomal rearrangements.

Deletions of chromosome 10q23 including the PTEN (phosphatase and tensin homolog) locus are known to occur in breast cancer patients. The PTEN gene is a phosphatase which metabolises PIP3, the lipid product of PI 3-kinase, directly opposing the activation of the oncogenic PI3K/AKT/mTOR signalling network. Inactivation of PTEN leads to constitutively activated levels of AKT, thus promoting cell growth, proliferation, survival and migration through multiple downstream effectors. PTEN is one of the most frequently deleted genes in various human cancer types. In breast cancer, the frequency of PTEN deletions or reduced expression varies from 4 % to 63 %.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All stages of female patients with breast cancer. Median age was 63 (range 20-100) years

Description

Inclusion Criteria:

  • all stages of breast cancer in females.

Exclusion Criteria:

  • breast cancer in males.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of chromosome 10q23 deletion including PTEN locus in breast cancer patients.
Time Frame: baseline
Correlation between PTEN deletion and clinicopathological characteristics in breast cancer patients.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Collaborators

principle investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

January 30, 2025

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • FISH in breast cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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