NCT06531902

Brief Summary

The current study will compare the blood expression level of lncRNA NNT-AS1 and hsa-miR-485-5p, as well as heat shock protein 90 (HSP90) serum levels in both healthy and CRC Egyptian patients' cohort peripheral blood samples. Second, examine if lncRNA NNT-AS1/hsa-miR-485 5p/HSP90 axis, or individually investigated, would be used as a non-invasive molecular precision biomarker in liquid biopsy for better diagnostic utility for CRC patients. Also, based on CRC patients' group stratification by histologic grades 1-3. Finally, investigate the probable link/correlation between lncRNA NNT-AS1/hsa-miR-485-5p/HSP90 as an axis or individually in CRC Egyptian patients' cohort in relation to demographic data or clinicopathological characteristics. All findings will be confirmed or ruled out by in silico means as well.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

May 16, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

Colorectal cancerLncRNA NNT-AS1Hsa-miR-485-5pHSP90Prognositic molecular biomarkers

Outcome Measures

Primary Outcomes (4)

  • determination ofncRNA Expression pattern in CRC patients' in comparison to the control group

    9 months

  • determination of HSP90 protein concentration in control and CRC cases

    12 months

  • assigning Correlation coefficient between ncRNA, HSP90 protein, CEA, and CA19-9

    10 months

  • carry out hsa-miR-485-5p target analysis

    3 months

Study Arms (2)

Patient group

A total of 60 CRC pateints' were enrolled in the study. CRC pateints' were treatment-naïve Egyptian patients' cohort admitted to the Clinical Oncology Clinic, National Cancer Institute (NCI), Cairo University, Cairo, Egypt. Male-to-female 1:1 (30/30) and their age range 24-76 years.

Healthy Control

28 age-matched and sex-matched apparently healthy volunteers, randomly selected from subjects enlisted during normal check-up examination or during blood donation. The control group participants were not taking any medication or suffering from any disease. Controls age range is 40-60 years and 13:15 male-to-female.

Eligibility Criteria

Age24 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

3.1. Patients group A total of 60 CRC pateints' were enrolled in the study. CRC pateints' were treatment-naïve Egyptian patients' cohort admitted to the Clinical Oncology Clinic, National Cancer Institute (NCI), Cairo University, Cairo, Egypt. Male-to-female 1:1 (30/30) and their age range 24-76 years. 3.2. Control group 28 age-matched and sex-matched apparently healthy volunteers, randomly selected from subjects enlisted during normal check-up examination or during blood donation. The control group participants were not taking any medication or suffering from any disease. Controls age range is 40-60 years and 13:15 male-to-female.

You may qualify if:

  • CRC diagnosed patients that is clinically confirmed by colonoscopy, abdominal radio-imaging, and histopathologicaly.

You may not qualify if:

  • individuals receiving chemotherapy, radiation, or undergone surgery
  • patients with blood disorders
  • patients with any cancer other than CRC.
  • Individuals with inadequate data or missing histopathological diagnoses
  • distant metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab

Cairo, 11566, Egypt

Location

Related Publications (1)

  • El-Sheikh NM, Abulsoud AI, Fawzy A, Wasfey EF, Hamdy NM. LncRNA NNT-AS1/hsa-miR-485-5p/HSP90 axis in-silico and clinical prospect correlated-to histologic grades-based CRC stratification: A step toward ncRNA Precision. Pathol Res Pract. 2023 Jul;247:154570. doi: 10.1016/j.prp.2023.154570. Epub 2023 May 24.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Five milliliters of peripheral venous blood liquid biopsy were collected from the antecubital vein from controls and CRC patients into clot activator polymer gel vacutainers (Greiner Bio-One GmbH, Australia). Vacutainers of completely coagulated samples were centrifuged at 4000 r.p.m for 10 min at room temperature (25 ◦C). The collected serum was aliquoted and kept at - 80 ◦C in three DNase/ RNase free Eppendorf tubes until analysis.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal 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
PRINCIPAL INVESTIGATOR
PI Title
professor of biochemistry and molecular biology

Study Record Dates

First Submitted

May 16, 2024

First Posted

August 1, 2024

Study Start

October 1, 2020

Primary Completion

March 1, 2021

Study Completion

June 1, 2021

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations