Assessment Of Long Noncoding RNA CCAT1 In Colorectal Cancer Patients

July 7, 2020 updated by: Alyaa Abd El-Rasoul Sayed Refae, Assiut University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

normal healthy individuals. precancerous colorectal diseases colorectal cancer

Description

Inclusion Criteria:

  • Patients newly diagnosed with colorectal cancer

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CRC group
patients with colorectal cancer
Diagnostic test: CCAT1
Long Non coding RNA
Control group
The control population comprised normal healthy individuals.
Diagnostic test: CCAT1
Long Non coding RNA
Precancerous group
patients with precancerous colorectal diseases
Diagnostic test: CCAT1
Long Non coding RNA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the diagnostic value of long noncoding RNA (CCAT1) expression
Time Frame: baseline
Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in diagnosis of colorectal cancer patients & its relation to tumor staging.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCAT1 in colorectal cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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