NCT04269746

Brief Summary

  1. 1.Evaluate the diagnostic value of long noncoding RNA (CCAT1) expression by RT-PCR in peripheral blood in colorectal cancer patients versus normal healthy control personal.
  2. 2.Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in diagnosis of colorectal cancer patients \& its relation to tumor staging.
  3. 3.Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in precancerous colorectal diseases.
  4. 4.Compare long noncoding RNA (CCAT1) expression with traditional marker; carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) in diagnosis of colorectal cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 8, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 12, 2020

Last Update Submit

July 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the diagnostic value of long noncoding RNA (CCAT1) expression

    Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in diagnosis of colorectal cancer patients \& its relation to tumor staging.

    baseline

Study Arms (3)

Control group

The control population comprised normal healthy individuals.

Diagnostic Test: CCAT1

Precancerous group

patients with precancerous colorectal diseases

Diagnostic Test: CCAT1

CRC group

patients with colorectal cancer

Diagnostic Test: CCAT1

Interventions

CCAT1DIAGNOSTIC_TEST

Long Non coding RNA

CRC groupControl groupPrecancerous group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

normal healthy individuals. precancerous colorectal diseases colorectal cancer

You may qualify if:

  • Patients newly diagnosed with colorectal cancer

You may not qualify if:

  • \. Patients with colorectal cancer that had been received chemotherapy, radiotherapy or surgical treatment.
  • \. History of non-precancerous benign colorectal diseases (Irritable bowel syndrome, colitis, appendicitis, diverticulitis, paralytic ileus \& intussusception).
  • \. History of benign or malignant tumors in other organs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zhao B, Lu M, Wang D, Li H, He X. Genome-Wide Identification of Long Noncoding RNAs in Human Intervertebral Disc Degeneration by RNA Sequencing. Biomed Res Int. 2016;2016:3684875. doi: 10.1155/2016/3684875. Epub 2016 Dec 20.

    PMID: 28097131BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Alyaa Refae, master

CONTACT

mohamed seddik, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

December 1, 2020

Primary Completion

March 1, 2021

Study Completion

September 1, 2021

Last Updated

July 8, 2020

Record last verified: 2020-02