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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-NDMH-5101_240046 | Other Grant/Funding Number | EIT-Health |
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| Name | Class |
|---|---|
| Hospital Universitario Ramon y Cajal | OTHER |
| Hospital de Santa Maria, Lisbon | UNKNOWN |
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The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are:
Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PreveCol test after a FOBT positive result | Other | Average-risk participants from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Diagnostic Test | PreveCol test based on blood sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic value | Value of efficiency through the clinical performance (sensitivity, specificity, positive predictive value and negative predictive value) of PreveCol® after FOBT positive result for detecting neoplastic lesions. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of cancer | Value of PreveCol's efficiency in second line for detecting cancer | 12 months |
| Diagnostic performance of lesions | Value of PreveCol's efficiency in second line for advanced lesions |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Measure the percentage of adverse events and complications directly/indirectly related to interventions of study. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Jimenez, PhD | Contact | +34 637899149 | mjimenez@amadix.com |
| Name | Affiliation | Role |
|---|---|---|
| Agustin Albillos, MD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Ana Rita, MD | Hospital de Santa Maria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Santa Maria | Not yet recruiting | Lisbon | Lisbon District | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36856579 | Background | Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1. | |
| 35914639 | Background | Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available. |
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Low-risk interventional study
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Laboratory Technicians
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| Survey using a questionnaire. | Other | Preference questionnaire for colorectal cancer screening methods |
|
| Survey using a questionnaire. | Other | PREMs for colorectal cancer screening programme |
|
| 12 months |
| Value of questionnaires into screening programme | The percentage of number of answers from each preference questions and PREMs | 12 months |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | Madrid | Spain |
|
| 28973514 | Background | Greuter MJE, de Klerk CM, Meijer GA, Dekker E, Coupe VMH. Screening for Colorectal Cancer With Fecal Immunochemical Testing With and Without Postpolypectomy Surveillance Colonoscopy: A Cost-Effectiveness Analysis. Ann Intern Med. 2017 Oct 17;167(8):544-554. doi: 10.7326/M16-2891. Epub 2017 Oct 3. |
| 25856688 | Background | Bujanda L, Sarasqueta C, Castells A, Pellise M, Cubiella J, Gil I, Cosme A, Arana-Arri E, Mar I, Idigoras I, Portillo I; EUSCOLON Study Investigators. Colorectal cancer in a second round after a negative faecal immunochemical test. Eur J Gastroenterol Hepatol. 2015 Jul;27(7):813-8. doi: 10.1097/MEG.0000000000000366. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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