Pathogenic microbes: an exploration for their driving role in colitis associated cancer

Pathogenic microbes: an exploration for their driving role in colitis associated cancer - Bacteria in Colitis associated cancer (BaCo)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43486

Enrollment

120

Registered

2016-09-12

Start date

2016-11-08

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colitis associated cancer colon cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For ulcerative colitis (N 8 years of disease duration * At time of colonoscopic surveillance in clinical remission (Montreal score S0);For controls (N

Exclusion criteria

Exclusion criteria: Exclusion criteria for UC-patients and controls: * Oral antibiotics in last 3 months before colonoscopy (drastically affects the mucosal microbiota);Exclusion criteria for controls only: * No history of CRC and UC or other inflammatory disease of the intestine

Design outcomes

Primary

Measure	Time frame
Via the treating physician, patients scheduled for colonoscopy will be approached to participate in the study. Written information will be provided by mail, including informed consent forms, tubes for fecal collection and a short questionnaire. When written informed consent is obtained, biopsies will be collected from the patients. From healthy controls 3 biopsies from the left and 3 biopsies from the right sided colon will be collected. From UC patients, biopsies from healthy (2 extra biopsies), inflamed (2 extra biopsies) and suspected neoplastic lesions (2 extra biopsies) will be collected during scheduled colonoscopy. Tissue will be fixed in formalin (routine diagnostics) for pathology evaluation, snap frozen for DNA isolation and fixed in methacarn for biofilm analysis. 1) we will identify the bacterial biofilms in direct contact with the colon and assess whether bacteria invade the epithelium and colonic crypts (Methacarn fixed biopsies) 2) we will excise the bacterial biofilms with a laser-capture technique to identify the presence and expression of carcinogenic bacterial toxins within the biofilm (Methacarn fixed biopsies) 3) we will assess whether the presence of pathogenic bacteria or toxins are associated with oncogenic transition of the tissue by examining bacterial defense proteins, epithelial barrier function and activation of pro-carcinogenic signaling pathways. (formalin fixed biopsies) 4) we will identify bacteria or bacterial traits that can predict neoplastic lesions in UC-patients (snap frozen biopsies). The findings will be validated with DNA isolated from stool. Anticipated results: Insight in the relevance of pathogenic bacteria in biofilms in UC-patients during neoplasia development. A better understanding of CAC-pathogenesis will provide new tools for CAC prevention and diagnosis in patients with chronic UC. The results from this study do not have any implications for regular patient care and are solely of value f	—

Measure

Time frame

Via the treating physician, patients scheduled for colonoscopy will be approached to participate in the study. Written information will be provided by mail, including informed consent forms, tubes for fecal collection and a short questionnaire. When written informed consent is obtained, biopsies will be collected from the patients. From healthy controls 3 biopsies from the left and 3 biopsies from the right sided colon will be collected. From UC patients, biopsies from healthy (2 extra biopsies), inflamed (2 extra biopsies) and suspected neoplastic lesions (2 extra biopsies) will be collected during scheduled colonoscopy. Tissue will be fixed in formalin (routine diagnostics) for pathology evaluation, snap frozen for DNA isolation and fixed in methacarn for biofilm analysis. 1) we will identify the bacterial biofilms in direct contact with the colon and assess whether bacteria invade the epithelium and colonic crypts (Methacarn fixed biopsies) 2) we will excise the bacterial biofilms with a laser-capture technique to identify the presence and expression of carcinogenic bacterial toxins within the biofilm (Methacarn fixed biopsies) 3) we will assess whether the presence of pathogenic bacteria or toxins are associated with oncogenic transition of the tissue by examining bacterial defense proteins, epithelial barrier function and activation of pro-carcinogenic signaling pathways. (formalin fixed biopsies) 4) we will identify bacteria or bacterial traits that can predict neoplastic lesions in UC-patients (snap frozen biopsies). The findings will be validated with DNA isolated from stool. Anticipated results: Insight in the relevance of pathogenic bacteria in biofilms in UC-patients during neoplasia development. A better understanding of CAC-pathogenesis will provide new tools for CAC prevention and diagnosis in patients with chronic UC. The results from this study do not have any implications for regular patient care and are solely of value f

—

Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results