Colo-rectal CancerNCT06091592
The dıagnostıc Value of Serum autotaxın Level ın Colorectal Cancer
An observational study of Colo-rectal Cancer, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Colorectal cancer is one of the most common causes of cancer-related death. Early diagnosis is extremely important in terms of treatment and mortality. In this study, we investigated the diagnostic value of serum autotaxin levels in colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Serum autotaxın levels
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2020to 25 Dec 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The colorectal cancer patient group included clinical stage 1-3 patients of both sexes. Patients with metastatic disease, those who received neoadjuvant therapy, those who received systemic chemoradiotherapy, those who had any known systemic inflammatory or autoimmune disease, those with another concurrent malignancy, and those who had been previously diagnosed and treated for another malignancy were excluded from the study. The control group included healthy volunteers who had undergone screening colonoscopy within the last month, had no pathology, had not been diagnosed with any malignant disease before, had no known systemic inflammatory or autoimmune disease, and had not been diagnosed with inflammatory bowel disease.
Who may be able to join
- stage 1-3 colorectal cancer
- control group included healthy volunteers who had undergone screening colonoscopy within the last month , had no pathology,
Who cannot join
- metastatic disease,
- received neoadjuvant therapy
- received systemic chemoradiotherapy
- had any known systemic inflammatory or autoimmune disease
- had a with another concurrent malignancy
- had been previously diagnosed and treated for another malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dışkapı Yıldırım Beyazıt training and research hospital
Ankara, 06610
About this study
Official title: Serum autotaxın Level ın Colorectal Cancer
Colorectal cancer is one of the most common causes of cancer-related death. Early diagnosis is extremely important in terms of treatment and mortality. In this study, we investigated the diagnostic value of serum autotaxin levels in colorectal cancer.
Read the detailed description
Colorectal cancer (CRC) is the third most common type of cancer worldwide. Among the causes of death due to cancer; it is the second most common among both genders with a rate of 9.2% after lung cancer . Early detection of the disease is important for survival. National screening programs attempt to detect this disease at an early stage.
Autotaxin (ATX) molecule is a member of the nucleotide pyrophosphatase/phosphodiesterase enzyme family (ENNP), It is secreted at 125 kDa, has lysophospholipase D activity in the lysophosphatidic acid (LPA) pathway, and is located at the 24th locus of the long arm of the 8th chromosome. This is also called ENPP2. It was discovered to be an autocrine motility-stimulating factor released by human melanoma A-2058 cells . Lysophosphatidic acid (LPA) is a lipid signalling molecule located in the cell membrane. LPA functions as an autocrine/paracrine messenger through at least six G protein-coupled receptors (GPCR) known as LPA 1-6. It plays physiologically important roles in various cellular processes, including wound healing, differentiation, cell proliferation, and migration. The role of ATX in the bioactivity of LPA is correlated with the lysophosphatidyl-D (lysoPLD) activity of ATX. ATX molecule; With this enzyme activity, it plays a fundamental role in the conversion of lysophosphatidylcholine to lysophosphatidic acid . Many studies have demonstrated the biological effects of the autotaxin-lysophosphatidic acid (ATX-LPA) signalling pathway in cancer. In vitro and in vivo studies have shown that increased ATX-LPA signalling contributes to cancer initiation and progression. Current evidence supports the role of the ATX-LPA signalling pathway in the proliferation, invasion, adhesion, and angiogenesis of cells, and is effective in cancer development and metastasis. Increased ATX expression has been reported in various cancers, such as glioblastoma, hepatocellular and thyroid carcinomas, breast, pancreatic, colon, and hematological cancers .
The ATX molecule has the feature of being a molecule that will be effective in the future, not only in the diagnosis of cancer, but also in the treatment process and to be studied extensively. in this study, we aimed to examine the diagnostic and biological behaviour relationship between serum ATX levels and colorectal cancer and to determine the cut-off value for serum ATX levels in colorectal cancer.
Serum ATX levels were compared between the patient and control groups. ATX levels were analysed in subgroups formed according to the demographic, clinical, pathological, and laboratory characteristics of the patient group.
- Conditions
- Colo-rectal Cancer
- Being tested
- Serum autotaxın levels
- Keywords
- Colorectal cancer, autotaxın, biomarker
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum autotaxın levelsOther
Autotaxin molecule is a nucleotide pyrophosphatase/phosphodiesterase enzyme.
| Study group | Role | What they receive |
|---|---|---|
| Patient ( cancer) | . The colorectal cancer patient group included clinical stage 1-3 patients of both sexes. Patients with metastatic disease, those who received neoadjuvant therapy, those who received systemic chemoradiotherapy, those who had any known systemic inflammatory or autoimmune disease, those with another concurrent malignancy, and those who had been previously diagnosed and treated for another malignancy were excluded from the study. Receives: Other: Serum autotaxın levels | |
| Control (healthy volunteer) | The control group included healthy volunteers who had undergone screening colonoscopy within the last month, had no pathology, had not been diagnosed with any malignant disease before, had no known systemic inflammatory or autoimmune disease, and had not been diagnosed with inflammatory bowel disease. Receives: Other: Serum autotaxın levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum autotaxın level
The value measured by the Elisa method in blood samples taken from patients and healthy volunteers.
Measured: one years
Secondary outcomes (3)
Tumor location
It describes where this tumor is located in the colon in the patient group.
Measured: one years
TNM stages
It describes the pathological staging of colorectal cancer patients.according to American Joint Committee on Cancer (AJCC) TNM system.
Measured: one years
tumor differentiation grade
According to histopathological results, it is divided into three classes: well moderately and poor.
Measured: one years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start30 Dec 2020
- Primary completion20 Nov 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmail Oskay Kaya, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- ismail o kaya, Principal investigator, Dışkapı Yıldırım Beyazıt training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091592
- Sponsor's protocol ID
- DYB-GC-AB-01
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum autotaxın Level ın Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06091592
- Acronym / sponsor ID
- DYB-GC-AB-01
- Conditions
- Colo-rectal Cancer
- Keywords
- Colorectal cancer, autotaxın, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 19 Oct 2023 (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.
Colorectal cancer is one of the most common causes of cancer-related death. Early diagnosis is extremely important in terms of treatment and mortality. In this study, we investigated the diagnostic value of serum autotaxin levels in colorectal cancer.
Detailed description
Colorectal cancer (CRC) is the third most common type of cancer worldwide. Among the causes of death due to cancer; it is the second most common among both genders with a rate of 9.2% after lung cancer . Early detection of the disease is important for survival. National screening programs attempt to detect this disease at an early stage.
Autotaxin (ATX) molecule is a member of the nucleotide pyrophosphatase/phosphodiesterase enzyme family (ENNP), It is secreted at 125 kDa, has lysophospholipase D activity in the lysophosphatidic acid (LPA) pathway, and is located at the 24th locus of the long arm of the 8th chromosome. This is also called ENPP2. It was discovered to be an autocrine motility-stimulating factor released by human melanoma A-2058 cells . Lysophosphatidic acid (LPA) is a lipid signalling molecule located in the cell membrane. LPA functions as an autocrine/paracrine messenger through at least six G protein-coupled receptors (GPCR) known as LPA 1-6. It plays physiologically important roles in various cellular processes, including wound healing, differentiation, cell proliferation, and migration. The role of ATX in the bioactivity of LPA is correlated with the lysophosphatidyl-D (lysoPLD) activity of ATX. ATX molecule; With this enzyme activity, it plays a fundamental role in the conversion of lysophosphatidylcholine to lysophosphatidic acid . Many studies have demonstrated the biological effects of the autotaxin-lysophosphatidic acid (ATX-LPA) signalling pathway in cancer. In vitro and in vivo studies have shown that increased ATX-LPA signalling contributes to cancer initiation and progression. Current evidence supports the role of the ATX-LPA signalling pathway in the proliferation, invasion, adhesion, and angiogenesis of cells, and is effective in cancer development and metastasis. Increased ATX expression has been reported in various cancers, such as glioblastoma, hepatocellular and thyroid carcinomas, breast, pancreatic, colon, and hematological cancers .
The ATX molecule has the feature of being a molecule that will be effective in the future, not only in the diagnosis of cancer, but also in the treatment process and to be studied extensively. in this study, we aimed to examine the diagnostic and biological behaviour relationship between serum ATX levels and colorectal cancer and to determine the cut-off value for serum ATX levels in colorectal cancer.
Serum ATX levels were compared between the patient and control groups. ATX levels were analysed in subgroups formed according to the demographic, clinical, pathological, and laboratory characteristics of the patient group.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient ( cancer) | – | Other: Serum autotaxın levels. The colorectal cancer patient group included clinical stage 1-3 patients of both sexes. Patients with metastatic disease, those who received neoadjuvant therapy, those who received systemic chemoradiotherapy, those who had any known systemic inflammatory or autoimmune disease, those with another concurrent malignancy, and those who had been previously diagnosed and treated for another malignancy were excluded from the study. |
| Control (healthy volunteer) | – | Other: Serum autotaxın levelsThe control group included healthy volunteers who had undergone screening colonoscopy within the last month, had no pathology, had not been diagnosed with any malignant disease before, had no known systemic inflammatory or autoimmune disease, and had not been diagnosed with inflammatory bowel disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The colorectal cancer patient group included clinical stage 1-3 patients of both sexes. Patients with metastatic disease, those who received neoadjuvant therapy, those who received systemic chemoradiotherapy, those who had any known systemic inflammatory or autoimmune disease, those with another concurrent malignancy, and those who had been previously diagnosed and treated for another malignancy were excluded from the study. The control group included healthy volunteers who had undergone screening colonoscopy within the last month, had no pathology, had not been diagnosed with any malignant disease before, had no known systemic inflammatory or autoimmune disease, and had not been diagnosed with inflammatory bowel disease.
Key inclusion criteria (2 listed)
- stage 1-3 colorectal cancer
- control group included healthy volunteers who had undergone screening colonoscopy within the last month , had no pathology,
Key exclusion criteria (6 listed)
- metastatic disease,
- received neoadjuvant therapy
- received systemic chemoradiotherapy
- had any known systemic inflammatory or autoimmune disease
- had a with another concurrent malignancy
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 |
|---|---|---|
| Serum autotaxın levelsAutotaxin molecule is a nucleotide pyrophosphatase/phosphodiesterase enzyme. | Other | Control (healthy volunteer), Patient ( cancer) |
Primary outcome
Serum autotaxın level
Time frame: one years
The value measured by the Elisa method in blood samples taken from patients and healthy volunteers.
3 secondary outcomes
Tumor location
Time frame: one years
TNM stages
Time frame: one years
tumor differentiation grade
Time frame: one years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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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.
ismail o kaya principal investigator
Dışkapı Yıldırım Beyazıt training and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum autotaxın level (time frame: one years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2023.