Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452745
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-05
Brief Title:
Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile
Sponsor:
Institut Investigacio Sanitaria Pere Virgili
Organization:
Institut Investigacio Sanitaria Pere Virgili
Study Overview
Official Title:
Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EarlyCRC
Brief Summary:
Colorectal cancer is the most frequent tumor in our environment if both sexes are considered together Every year almost 800 cases are diagnosed in the districts of Tarragona A little more than half of colorectal cancers are cured with surgery with or without the addition of complementary treatments with chemotherapy andor radiation therapy Those who are not cured is because at the time of diagnosis the disease has already spread or they spread after having been treated surgically with curative intent
The purpose of the EarlyCRC project is to determine whether metabolites substances of low molecular weight can be found in the urine and stool of patients with colorectal cancer or polyps that can be easily and cheaply differentiated urine or stool analysis between the patients affected by colorectal cancer or polyps from healthy individuals For the identification of these possible metabolites the urine analysis will be performed using the usual techniques in metabolomics which studies the existing metabolites in biological processes
The purpose of the EarlyCRC project is to determine whether metabolites substances of low molecular weight can be found in the urine and stool of patients with colorectal cancer or polyps that can be easily and cheaply differentiated urine or stool analysis between the patients affected by colorectal cancer or polyps from healthy individuals For the identification of these possible metabolites the urine analysis will be performed using the usual techniques in metabolomics which studies the existing metabolites in biological processes
Detailed Description:
Colorectal cancer CRC is the most frequent neoplasm in our environment if both sexes are considered together It is the second most common neoplasm in women after breast cancer and the second most common in men after prostate cancer In terms of mortality CRC is the second leading cause of cancer death in men after lung cancer and second in women after breast cancer For the year 2013 735 cases and 262 deaths from colorectal cancer were estimated in the province of Tarragona Since 1982 incidence rates have increased annually by more than 3 in men and by almost 2 in women It is estimated that if no early diagnosis program was carried out in 2020 about 900 new cases of CRC would be diagnosed and about 300 deaths would occur1
These figures vary according to one or other geographical areas of the world If we consider the European population as a whole colorectal cancer is the third most common tumor for both sexes together after breast cancer and prostate cancer It is the third most common tumor in men after prostate cancer and lung cancer and the second most common in women after breast cancer The mortality figures in Europe place colorectal cancer in third place for both sexes together after lung and breast cancer so that in men it is surpassed only by lung cancer and in women by breast cancer2
As in the vast majority of cancers age is the main non-modifiable risk factor for colon and rectal cancer More than 90 of cases are diagnosed in people over 50 years old There is an increased risk of CRC in those with hereditary diseases such as familial colonic polyposis or Lynch syndrome although the vast majority of colorectal cancers more than 90 of cases do not have a hereditary component With respect to the modifiable risk factors one of the most important is the consumption of red and processed meat or meat that is heavily cooked or cooked in direct contact with fire On the other hand fiber fruit and vegetable consumption as well as dairy and micronutrients such as folate and calcium are protective against this cancer All these dietary factors affect the risk of the appearance of the precursor lesions of cancer colorectal adenomas Obesity is another risk factor and exercise and physical activity act as protectors Thus CRC is considered to be caused by a combination of genetic and environmental factors which lead to the appearance of adenomatous polyps as a premalignant lesion and which over time acquire new mutations in their genetic material until become an adenocarcinoma13
The early diagnosis of cancer and more specifically that of colorectal cancer aims to detect colorectal tumors in the initial stages as well as premalignant lesions colonic polyps As with all neoplastic diseases the stage at the time of diagnosis is the most important prognostic factor when it comes to survival In this way it has been shown that a test capable of easily and minimally invasively diagnosing the initial stages of colorectal cancer can reduce mortality from this tumor by 15-20 in program participants4 The fact of being able to detect benign polyps not only reduces mortality from colorectal cancer but also decreases its incidence since the removal of polyps prevents their subsequent malignancy Currently the test used in the early diagnosis of colorectal cancer is the determination of occult blood in faeces from the age of 50 every two years In the event that the test comes out positive the patient is subsequently subjected to a colonoscopic study Collection of the faecal sample by itself may have low acceptance and therefore may compromise population participation in screening A urine test with an easier and cleaner collection technique could be an added advantage in an early diagnosis program
These figures vary according to one or other geographical areas of the world If we consider the European population as a whole colorectal cancer is the third most common tumor for both sexes together after breast cancer and prostate cancer It is the third most common tumor in men after prostate cancer and lung cancer and the second most common in women after breast cancer The mortality figures in Europe place colorectal cancer in third place for both sexes together after lung and breast cancer so that in men it is surpassed only by lung cancer and in women by breast cancer2
As in the vast majority of cancers age is the main non-modifiable risk factor for colon and rectal cancer More than 90 of cases are diagnosed in people over 50 years old There is an increased risk of CRC in those with hereditary diseases such as familial colonic polyposis or Lynch syndrome although the vast majority of colorectal cancers more than 90 of cases do not have a hereditary component With respect to the modifiable risk factors one of the most important is the consumption of red and processed meat or meat that is heavily cooked or cooked in direct contact with fire On the other hand fiber fruit and vegetable consumption as well as dairy and micronutrients such as folate and calcium are protective against this cancer All these dietary factors affect the risk of the appearance of the precursor lesions of cancer colorectal adenomas Obesity is another risk factor and exercise and physical activity act as protectors Thus CRC is considered to be caused by a combination of genetic and environmental factors which lead to the appearance of adenomatous polyps as a premalignant lesion and which over time acquire new mutations in their genetic material until become an adenocarcinoma13
The early diagnosis of cancer and more specifically that of colorectal cancer aims to detect colorectal tumors in the initial stages as well as premalignant lesions colonic polyps As with all neoplastic diseases the stage at the time of diagnosis is the most important prognostic factor when it comes to survival In this way it has been shown that a test capable of easily and minimally invasively diagnosing the initial stages of colorectal cancer can reduce mortality from this tumor by 15-20 in program participants4 The fact of being able to detect benign polyps not only reduces mortality from colorectal cancer but also decreases its incidence since the removal of polyps prevents their subsequent malignancy Currently the test used in the early diagnosis of colorectal cancer is the determination of occult blood in faeces from the age of 50 every two years In the event that the test comes out positive the patient is subsequently subjected to a colonoscopic study Collection of the faecal sample by itself may have low acceptance and therefore may compromise population participation in screening A urine test with an easier and cleaner collection technique could be an added advantage in an early diagnosis program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None