Emerging Role of NOTCH-related Long Non-coding RNA(s) as Biomarkers in Liquid Biopsy From Colorectal Cancer Patients

NCT06432413 | Completed

• 1 other identifier: RHDIRB2020110301 REC #15
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This work aims to Investigate the role of circulating notch associated lncRNAs SNHG3 and LUNAR1 as possible non invasive prognostic biomarkers for colorectal cancer (CRC) monitoring via measuring the gene expression level of lncRNAs SNHG3 and LUNAR1 in serum of CRC patients compared with control subjects. Also, to investigate the correlation between SNHG3 and LUNAR1 expression levels and CRC clinicopathological features and their relevance for CRC patients' clinico-pathological features outcomes assessment

Conditions

Colorectal Cancer

Keywords

Notch; SNHG3; LUNAR1; lncRNAs; colorectal cancer; prognosis; epigenetics

Outcome Measures

Primary Outcomes (1)

• measure the expression level and pattern of Notch-associated lncRNAs SNHG3 and LUNAR1 in peripheral blood liquid biopsy in relation to clinico-pathological tumor features.

  the expression level and pattern of Notch-associated lncRNAs SNHG3 and LUNAR1 in peripheral blood liquid biopsy, polled from treatment-naïve Egyptian CRC patients' cohort, compared to age-matched and sex-matched apparently healthy volunteer subjects as controls.

  18 months

Study Arms (2)

Patients group

70 CRC Egyptian patients, admitted to the Oncology Center of the Faculty of Medicine, Ain Shams University Hospitals or the Oncological Surgery Department of Dar-El-Shafa Hospital, before surgical treatment or CRC neo-adjuvant treatment, if they were eligible and agreed to participate (signed the Informed consent) were recruited in the research.

Apparently healthy control group

26 randomly-chosen, age-matched, and sex-matched healthy subjects served as the control group. Control group subjects were chosen from those who came to visit hospital workers in the hospital or from blood donors at the ASUH Blood Donation Unit. None of the control group did take any medications or have any diseases upon questioner and blood samples was taken for CBC.

Eligibility Criteria

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

Study Population

for Patients group. CRC Egyptian patients, who admitted to the Oncology Center of the Faculty of Medicine, Ain Shams University Hospitals (ASUH) or the Oncological Surgery Department of Dar-El-Shafa Hospital, before surgical treatment or CRC neo-adjuvant treatment, if they were eligible and agreed to participate (signed the I.C) were recruited in the research. Apparently healthy control group. randomly-chosen, age-matched, and sex-matched healthy subjects served as the control group. Control group subjects were chosen from those who came to visit hospital workers in the hospital or from blood donors at the ASUH Blood Donation Unit. None of the control group did take any medications or have any diseases upon questioner and blood samples was taken for CBC.

You may qualify if:

• Patients, came to the Oncology Center of ASUH or the Oncological Surgery Department of Dar-El-Shafa Hospital, who experienced a range of colonic symptoms, such as constipation, ab-dominal discomfort, rectal bleeding, and abrupt weight loss were included in the study when di-agnosis of CRC was clinically confirmed by abdominal radiography, colonoscopy, and histo-pathology.

You may not qualify if:

• patients who received chemotherapy, radiotherapy or undergone surgery. Patients with other types of cancer were also excluded. Individuals with missing data were not included.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Pharmacy, Ain Shams University, AdvancedBiochemistry Research Lab

Cairo, 11566, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

five milliliters of peripheral venous blood fluid biopsy were collected and stored in clot-activating polymer gel vacutainers (Greiner Bio-One GmbH, Australia). The samples were centrifuged in vacutainers at a speed of 4000 rpm for ten minutes at room temperature (25°C). The obtained serum was aliquoted and stored at -80°C in RNAse-free Eppendorf tubes. Using the miRNeasy Mini kit (Cat. No. 217004; Qiagen, Hilden, Germany), total RNA was isolated from sera in accordance with the protocol's instructions. Aliquots of the extracted RNA were kept at -80°C after being dissolved in 30 μl of RNase-free water.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nadia Hamdy, PhD

  Faculty of pharmacy Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: June 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

EG (1)