Partial PTEN Deletion in Breast Cancer

PTEN Gene Deletion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05111080
• Other study ID #: FISH in breast cancer
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: January 30, 2025

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Fatma Refaat Ibrahim, resident doctor
• Phone: 01032073035
• Email: drfatmarefaat[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• Detection of chromosome 10q23 deletion including PTEN locus in breast cancer patients.

• Correlation between PTEN deletion and clinicopathological characteristics in breast cancer patients.

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 %.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 30, 2025
• Est. primary completion date: December 30, 2024
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• all stages of breast cancer in females.

Exclusion Criteria:

• breast cancer in males.

Related Conditions & MeSH terms

• PTEN Gene Deletion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	principle investigator

References & Publications (1)

Young PA, Kaiser II. Aminoacylation of Escherichia coli cysteine tRNA by selenocysteine. Arch Biochem Biophys. 1975 Dec;171(2):483-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of chromosome 10q23 deletion including PTEN locus in breast cancer patients.	Correlation between PTEN deletion and clinicopathological characteristics in breast cancer patients.	baseline