Colorectal CancerNCT04269746
Assessment Of Long Noncoding RNA CCAT1 In Colorectal Cancer Patients
An observational study of Colorectal Cancer, run by Assiut University.
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.
About this study
Official title: Assessment Of Long Noncoding RNA CCAT1 Using Real Time -Polymerase Chain Reaction In Colorectal Cancer Patients
- 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.
- Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in diagnosis of colorectal cancer patients \& its relation to tumor staging.
- Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in precancerous colorectal diseases.
- 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.
- Conditions
- Colorectal Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Control group | The control population comprised normal healthy individuals. Receives: Diagnostic Test: CCAT1 | |
| Precancerous group | patients with precancerous colorectal diseases Receives: Diagnostic Test: CCAT1 | |
| CRC group | patients with colorectal cancer Receives: Diagnostic Test: CCAT1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 Feb 2020
- Study startDec 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyaa Abd El-Rasoul Sayed Refae, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Long Noncoding RNA CCAT1 Using Real Time -Polymerase Chain Reaction In Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT04269746
- Acronym / sponsor ID
- CCAT1 in colorectal cancer
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in diagnosis of colorectal cancer patients \& its relation to tumor staging.
- Evaluate the clinical utility of detecting long noncoding RNA (CCAT1) expression in precancerous colorectal diseases.
- Compare long noncoding RNA (CCAT1) expression with traditional marker; carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) in diagnosis of colorectal cancer.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: CCAT1The control population comprised normal healthy individuals. |
| Precancerous group | – | Diagnostic Test: CCAT1patients with precancerous colorectal diseases |
| CRC group | – | Diagnostic Test: CCAT1patients with colorectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- normal healthy individuals. precancerous colorectal diseases colorectal cancer
Key inclusion criteria (1 listed)
- Patients newly diagnosed with colorectal cancer
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCAT1Long Non coding RNA | Diagnostic test | CRC group, Control group, Precancerous group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 28097131Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.