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| Name | Class |
|---|---|
| Janssen Pharmaceutica N.V., Belgium | INDUSTRY |
| KU Leuven | OTHER |
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The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collected. Sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control | Patients undergoing lower GI endoscopy without any colorectal adenoma or carcinoma. |
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| Adenoma | Patients undergoing lower GI endoscopy with presence of colorectal adenoma detected. |
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| Colorectal cancer | Patients diagnosed with colorectal cancer and referred to surgical carcinoma resection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon biopsies | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differential host microbiome composition and abundance in healthy, adenoma and CRC patients and its correlation to CRC risk features and host genomic and transcriptomic components. | Host microbiome composition and abundance data will be generated from saliva, stool and colonic biopsies with amplicon-based 16S ribosomal RNA sequencing. This data will be correlated to CRC risk factors collected in a questionnaire covering lifestyle, diet and medical history as well as host genomic and transcriptomic profiling generated by targeted gene sequencing and microarray-based gene expression profiling. | 2 years |
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Lower GI endoscopy patients
Inclusion Criteria:
Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
Male or female, aged 18 years or above
Referred to lower GI endoscopy. Referral reasons can be among others:
Both self-referrals, referrals from external GP or specialists and internal referrals can be included.
Exclusion Criteria:
CRC patients
Inclusion criteria:
Exclusion Criteria:
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Study participants are patients with CRC that will undergo surgical tumor resection or patients referred for lower GI endoscopy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | Flemish Brabant | 3000 | Belgium | ||
| Academisch Medisch Centrum |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007414 | Intestinal Neoplasms |
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Saliva Stool Tissue
| Amsterdam |
| 1105 AZ |
| Netherlands |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |