"Studying The Role of Key Epigenetic Mediators in Breast Cancer Patients"

NCT06759714 | Recruiting

• 1 other identifier: RHDIRB2020110301REC#292
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The role of epigenetic regulators and their dysregulation in cancer have gained much attention recently, as they influence the gene expression of many oncogenes and tumor suppressor genes. Non-coding RNAs (ncRNAs) including (lncRNAs and miRNAs) and chromatin remodeling machinery proteins are key epigenetic regulators playing a key role in carcinogenesis. In addition, they can serve as diagnostic and prognostic markers in many cancer types including breast cancer. Therefore, studying these molecular markers will help in the diagnosis and prognosis as well as in the better understanding of this devastating disease.To the best of our knowledge, This is the first research work measuring the expression level of UPK1A-AS1 and/or UNC5B-AS1 in breast cancer clinical samples. These data could provide a promising approach in introducing a novel markers that help in the diagnosis and prognosis of breast cancer and provide a potential targets for gene therapy.

Conditions

Breast Cancer

Keywords

Breast cancer; lncRNA; miRNA; unc5b-as1; upk1a-as1; G9a

Outcome Measures

Primary Outcomes (4)

• Elucidate the role of our candidate lncRNAs and their downstream targets obtained from breast cancer patients' liquid biopsy and/or tissue samples.

  around 12 months

• Compare the expression level of lncRNA UPK1A- AS1 and/or UNC5B-AS1 and their target miRNAs in serum samples (liquid biopsy) and/or tissue samples from breast cancer patients, using (qRT-PCR) to their expression in healthy volunteers

  around 12 months

• Compare serum and/or tissue target proteins level, by ELISA to their levels in healthy volunteers.

  around 12 months

• Correlate these ncRNAs and target protein level axis, to the clinicopathological characteristics of breast cancer

  around 12 months

Study Arms (2)

Study group

Malignant non-metastatic breast cancer patients; newly diagnosed breast cancer patients.

Control group

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Participants. A series of Egyptian female breast cancer patients will be recruited from the Breast Cancer Unit, Clinical Oncology Department, Ain Shams University, Cairo, Egypt.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of pharmacy, Ain Shams University

Cairo, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Sampling: 6 mls peripheral blood will be collected into polymer gel vacutainers with clot activator (Greiner Bio-One GmbH, Australia), left for 15 min. at room temperature to clot, followed by a 10 min. centrifugation at 10,000g at 4°C, sera obtained will be aliquoted into 5 clean Eppendorf tubes and stored at -80°C, until biochemical assessment at Biochemistry Department, Faculty of Pharmacy, Ain-Shams University. Stored sera will be used for ELISA technique measurements of target protein levels, using commercially available ELISA kits according to the manufacturer's instructions. Genomic RNA will be extracted; ncRNAs extraction from serum samples and purification evaluation. ncRNAs expression level quantification, using qRT-PCR by step one plus. We will proceed with total RNA extraction from serum sample using miRNeasy Mini Kit. The c-DNA synthesis will be done afterwards using VERSO c-DNA synthesis kit (Thermo Scientific, USA). Next, we will carry out RT PCR.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sherihan Galal, phD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherihan Galal, phD

CONTACT

01022850699; Dr.sherehan@pharma.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Biochemistry, Faculty of pharmacy, ASU

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: January 6, 2025
• Study Start: November 23, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

EG (1)