Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06452745 |
| Other study ID # |
114/2019 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2019 |
| Est. completion date |
June 30, 2026 |
Study information
| Verified date |
June 2024 |
| Source |
Institut Investigacio Sanitaria Pere Virgili |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 and/or 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.
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 adenocarcinoma1,3.
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.
