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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01814-43 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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Familial adenomatous polyposis (FAP) is an autosomal dominant inherited disorder linked to a mutation in the APC gene, associated with the development of multiple colonic and duodenal adenomas, which in 100% of cases progress to colorectal cancer (CRC) if left untreated. Management of affected patients is usually based on prophylactic total colectomy with or without rectal preservation, followed by regular endoscopic surveillance of the duodenum and rectum or ileal reservoir. However, there is considerable inter- and intra-familial variability in the rate of adenoma appearance and development for identical mutations. This strongly suggests the additional role of environmental factors. Recently, the gut microbiota has been identified as a co-factor of carcinogenesis in patients with FAP, but no prospective evaluation of the association between the incidence and severity of adenomatous proliferations and a microbiological signature has been studied, particularly at duodenal level in operated patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with genetically proven familial adenomatous polyposis undergoing surgery | Patients with familial adenomatous polyposis hospitalized for regular endoscopic follow-up by upper and lower digestive endoscopy at Hôpital Edouard Herriot, Lyon, France or Hôpital de la Croix-Rousse, Lyon, France |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sampling of feces and duodenal fluids | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota composition | Analysis of fecal microbiota composition as a function of the cumulative number of reservoir (rectum or ileal) adenomas treated over 3 consecutive endoscopies | Within 48 hours of endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with proven familial adenomatous polyposis genetically operated (total colectomy with ileoanal or ileorectal anastomosis), included in the national POLYPOSE database and with regular endoscopic follow-up with upper and lower GI endoscopy at Hôpital Edouard Herriot, Lyon, France or Hôpital de la Croix-Rousse, Lyon, France
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas BENECH, MD PhD | Contact | +33426109435 | +33 | nicolas.benech@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot | Recruiting | Lyon | France | 69003 | France |
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| Hôpital de la Croix Rousse | Recruiting | Lyon | France | 69004 | France |
|
| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012002 | Rectal Diseases |
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