NCT06091592

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 14, 2023

Last Update Submit

October 14, 2023

Conditions

Keywords

Colorectal cancerautotaxınbiomarker

Outcome Measures

Primary Outcomes (1)

  • Serum autotaxın level

    The value measured by the Elisa method in blood samples taken from patients and healthy volunteers.

    one years

Secondary Outcomes (3)

  • Tumor location

    one years

  • TNM stages

    one years

  • tumor differentiation grade

    one years

Study Arms (2)

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.

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.

Other: Serum autotaxın levels

Interventions

Autotaxin molecule is a nucleotide pyrophosphatase/phosphodiesterase enzyme.

Control (healthy volunteer)Patient ( cancer)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • stage 1-3 colorectal cancer
  • control group included healthy volunteers who had undergone screening colonoscopy within the last month , had no pathology,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dışkapı Yıldırım Beyazıt training and research hospital

Ankara, 06610, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

5-10 ml of venous blood samples were taken from patients and healthy volunteers using blood collection tubes without anticoagulants.

MeSH Terms

Conditions

Colonic NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • ismail o kaya

    Dışkapı Yıldırım Beyazıt training and research hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 19, 2023

Study Start

December 30, 2020

Primary Completion

November 20, 2021

Study Completion

December 25, 2021

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations