NCT06427278

Brief Summary

Elucidate the role of lncRNA CCDC144NL-AS1, hsa-miR-143-3p, and HMGA2 protein as non-invasive epigenetic molecular biomarkers in liquid biopsy of CRC Egyptian patients, individually or as an interaction arm and in comparison, to the conventional protein TMs. In addition, the investigators investigated the potential role of lncRNA CCDC144NL-AS1 as a mediator for development and/or progression of the cancer phenotype as well as CRC metastasis and its relation to both hsa-miR-143-3p and HMGA2, clinically and in silico.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Typical duration 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

August 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

3.2 years

First QC Date

May 19, 2024

Last Update Submit

May 19, 2024

Conditions

Keywords

Colorectal cancerlncRNA CCDC144NL-AS1Hsa-miR-143-3pHMGA2Liquid biopsyIn silico analysis

Outcome Measures

Primary Outcomes (4)

  • Expression pattern of ncRNAs in CRC patients and controls

    9 months

  • HMGA2 protein concentration in CRC patients and controls

    12 months

  • Association of the investigated ncRNAs and HMGA2 with clinicopathological features of CRC patients

    12 months

  • Correlation between lncRNA CCDC144NL-AS1, hsa-miR-143-3p and HMGA2 and the conventional CRC TMs

    10 months

Study Arms (2)

Patient group

A total of 60 primary CRC treatment-naïve Egyptian patients admitted to the Dar Al Shefa Hospital, Cairo, Egypt, were enrolled in the study.

Healthy Control

30 age-matched and sex-matched apparently healthy volunteers, not receiving any medications or suffering from any disease, age range 30-60 years, were included as controls, male-to-female 1:1 (15/15). Control subjects were recruited randomly during routine check-up examinations for themselves or during blood donation.

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients group A total of 60 primary CRC treatment-naïve Egyptian patients admitted to the Dar Al Shefa Hospital, Cairo, Egypt, were enrolled in the study. Control group 30 age-matched and sex-matched apparently healthy volunteers, not receiving any medications or suffering from any disease, age range 30-60 years, were included as controls, male-to-female 1:1 (15/15). Control subjects were recruited randomly during routine check-up examinations for themselves or during blood donation.

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)

  • Abd El Fattah YK, Abulsoud AI, AbdelHamid SG, AbdelHalim S, Hamdy NM. CCDC144NL-AS1/hsa-miR-143-3p/HMGA2 interaction: In-silico and clinically implicated in CRC progression, correlated to tumor stage and size in case-controlled study; step toward ncRNA precision. Int J Biol Macromol. 2023 Dec 31;253(Pt 2):126739. doi: 10.1016/j.ijbiomac.2023.126739. Epub 2023 Sep 9.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Five milliliters of peripheral venous blood were withdrawn from controls and CRC patients, under strict sterile conditions, following standard international biosecurity safety procedures, into polymer gel clot activator vacutainers (Greiner Bio-One GmbH, Australia). At room temperature (25 ◦C), completely coagulated samples were centrifuged at 4000 rpm for 10 min. Sera obtained were aliquoted into three DNase/ RNase free Eppendorf tubes and stored at -80 ◦C for molecular 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 19, 2024

First Posted

May 23, 2024

Study Start

August 1, 2019

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations