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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00223-40 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Multicenter, inter-regional, case-control study with the primary objective of evaluating the discriminative power of the blood biomarker TFPI-1 to separate patients with histologically proven CRC from an asymptomatic control population between 50 and 75 years of age with normal colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | All consecutive patients from participating centers with an abnormal colonoscopy (presence of mucosal lesions at endoscopy), with histological confirmation of colorectal cancer. These will be patients with one or more histologically confirmed adenocarcinomatous lesions (CRC+) located in the colonic frame or rectum, with or without synchronous liver metastases. | ||
| Control group | All consecutive patients between 50 and 75 years of age for whom colonoscopy will be normal (no mucosal lesions). In this situation, histological examination is not performed. | ||
| Polyp group | All consecutive patients for whom colonoscopy shows mucosal lesions that will be classified as polyps after histological examination. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the ROC curve (AUC) of the TFPI-1 biomarker | the AUC of the TFPI-1 biomarker to separate the 2 groups (CRC+ and control, i.e., asymptomatic population between 50 and 75 years with normal colonoscopy). | At 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the TFPI-2 biomarker to separate the 2 groups (CRC+ and control). | At 2 months | |
| AUC of the discriminant score constructed by logistic regression with the 2 blood biomarkers as explanatory variables and the group type (CRC+ and control) as the variable to be explained. |
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Inclusion Criteria:
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Exclusion Criteria:
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Patients followed up for colonoscopy in the gastroenterology and digestive surgery departments of 5 regional hospitals in northern France
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe ZERBIB, MD,PhD | Contact | 0320445962 | +33 | philippe.zerbib@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe ZERBIB, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital HURIEZ - Chirurgie digestive et transplantation | Recruiting | Lille | France |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| At 2 months |
| Extension of c-index to the 3-group case proposed by Van Calster B et al. | At 2 months |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |