Colorectal Cancer Clinical Trial
Official title:
Νew Molecular Biomarkers for the Prevention and Early Detection of Precancerous or Cancerous Colorectal Lesions During Screening for Colorectal Cancer
NCT number | NCT02596113 |
Other study ID # | galanopoulosm |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | May 2018 |
Verified date | March 2019 |
Source | Evangelismos Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators designed a prospective study to evaluate the predictive ability of detection of mutations in genes involved in carcinogenesis of the colon (eg hMLH1, K-Ras, B-Raf, ccfDNA) in a sample of Greek population presents for conducting colonoscopy in the context of screening under international CRC prevention instructions. This investigation will be carried out in individuals in normal risk in order to study specific mutations (in blood and tissue) to draw reliable conclusions about whether we can detect (with greater sensitivity and specificity) patients with precancerous lesions or CRC with a simple blood test thereby reducing the cost and side effects of repeated endoscopic procedures.
Status | Completed |
Enrollment | 92 |
Est. completion date | May 2018 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: - normal risk for developing CRC aged 50-75 years who undergo preventive colonoscopy for polyps and CRC detection Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Greece | Evangelismos Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Evangelismos Hospital | National and Kapodistrian University of Athens |
Greece,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with no endoscopic findings | 1 month | ||
Primary | Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with adenomatous polyp bigger than 1 cm | 1 month | ||
Primary | Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with cancerous lesion | 1 month |
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