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Colorectal CancerNCT04269746

Assessment Of Long Noncoding RNA CCAT1 In Colorectal Cancer Patients

An observational study of Colorectal Cancer, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in diagnosis of colorectal cancer patients \& its relation to… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
CCAT1
How many people
100 participants
Where
No sites listed yet
Study dates
Dec 2020to Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: normal healthy individuals. precancerous colorectal diseases colorectal cancer

Who may be able to join

  • Patients newly diagnosed with colorectal cancer

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Alyaa Refae, master contact

+201091143302

alyaarefae@anu.edu.eg

mohamed seddik, PhD contact

+201020058069

moh-ismail310@yahoo.com

About this study

Official title: Assessment Of Long Noncoding RNA CCAT1 Using Real Time -Polymerase Chain Reaction In Colorectal Cancer Patients

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

Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the fourth leading cause of cancer mortality worldwide. Colorectal cancer is the 7th commonest cancer in Egypt, representing 3.47% of male cancers and 3% of female cancers. Cancer metastasis in the liver, which develops in 50% of CRC patients, represents the major cause of death in those patients .

CRC can be easily cured with surgery, if it is discovered and diagnosed early. Although in the recent years much progress has been achieved in screening for cancer, the prognosis of colorectal cancer is still poor. Colonoscopy is the standard screening method to detect early CRC .

Moreover, the other CRC screening tests (such as sigmoidoscopy, fecaloccult blood test (FOBT), tumor markers, fecal immunochemical test (FIT) and radiologic tests) have low sensitivity and specificity or high cost . Therefore, there is a great need for non-invasive and accurate biomarkers for detection of CRC.

Focusing into the physiological risk factors, genetic alterations may result from external influences like chemicals, radiation as well as pathogens (viruses) that disrupt the genome stability. Besides extensive studies on DNA damages in cell cycle regulation, past few decades evident the role of non-coding RNAs (ncRNAs) in the context of tumor biology. The existence of non-protein coding RNAs was known over years, where biological functions of these RNAs have been uncovered by progressive investigations. Non-coding RNAs have further classifications, among which the functions of micro RNAs (miRNAs) have been thoroughly explored. Thus, the concentration on the other type of ncRNA, the long non-coding RNAs (lncRNAs), is a yet emerging field in the research of cancer biology. A fraction of the genome comprises these lncRNAs who are actually poorly translated as compared to other protein coding counterparts.

LncRNAs are transcripts of longer than 200 bp.They have important roles in cellular processes like transcriptional regulation, chromosome remodeling, post-translational modifications and disruption in them may lead to disease conditions.

Colon cancer associated transcript-1 (CCAT1) is consistently upregulated in and is associated with pathogenesis of a number of malignancies, including gastric carcinoma, colon cancer, gallbladder cancer and hepatocellular carcinoma.

CCAT1 was identified initially in colon cancer Zhao (2016), who demonstrated that high expression of CCAT1 in CRC plasma may be used as predictive biomarker for screening of CRC.

The dysregulated expression of CCAT1 affects not only tumorigenesis, but also clinical manifestation, such as tumor size, lymph node metastasis, TNM stage, differentiation, invasion, patient survival and treatment outcome. This finding renders CCAT1 attractive as target for therapeutic intervention in cancer. The current available studies of the expression, clinical relevance, biological behavior and regulatory mechanism of CCAT1 in various cancers have been described. Also, the potential roles of CCAT1 in the diagnosis, prognostic evaluation and treatment of cancers have been discussed.

Being tested
CCAT1
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCAT1Diagnostic test

    Long Non coding RNA

Study groups in NCT04269746
Study groupRoleWhat they receive
Control groupThe control population comprised normal healthy individuals.
Receives: Diagnostic Test: CCAT1
Precancerous grouppatients with precancerous colorectal diseases
Receives: Diagnostic Test: CCAT1
CRC grouppatients with colorectal cancer
Receives: Diagnostic Test: CCAT1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionMar 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04269746
Sponsor's protocol ID
CCAT1 in colorectal cancer
Status last verified
Feb 2020
First submitted
12 Feb 2020
Last updated
8 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28097131

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alyaa Refae, master (+201091143302, alyaarefae@anu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the diagnostic value of long noncoding RNA (CCAT1) expression (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04269746, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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