Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal immunochemical test (FIT).
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Cross-sectional Multi-center Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
Overview
The investigators aim to evaluate and compare the diagnostic accuracy of FIT and the novel panel of bacterial gene markers (Fn, m3, Ch and Bc) collectively named as M3, in detecting colorectal advanced neoplasia.
Detailed description
Colorectal cancer (CRC) is the one of the most common cancers in Hong Kong with more than 5,500 new cases annually. There is prevailing evidence of increasing trend of young onset CRC globally. Early detection and resection of pre-malignant colorectal neoplasia has shown to reduce CRC-related mortality.
Non-invasive stool tests including guaiac-based faecal occult blood tests (gFOBT) and faecal immunochemical tests (FIT) are the cornerstones of population-based CRC screening programmes. The major limitation of this widely used strategy is its unsatisfactory sensitivities for CRC (79%) and advanced adenomas (AA; 40%). The sensitivity for non-advanced adenomas is even lower than 10%. A large proportion of advanced and non-advanced adenomas will be missed by FIT alone. Therefore, identification of alternative non-invasive test with better sensitivity to detect colorectal neoplasia is warranted.
Multitarget stool DNA test and faecal microbial DNA markers appear to be promising options for CRC screening. Several bacterial gene markers have been identified by metagenome sequencing and reported to be associated with CRC, including Fusobacterium nucleatum (Fn), Clostridium hathewayi (Ch) and Bacteroides clarus (Bc). However, these molecular markers had low accuracy in distinguishing adenomas from normal tissue. Recently, a new Lachnoclostridium gene marker (labelled as 'm3') has been shown to have high diagnostic yield for the detection of colorectal adenomas. In a case-control study of 1012 subjects, a linear increasing trend of m3 level was observed from fecal samples of healthy subjects to those with adenomas and cancers. The overall sensitivity of m3 was significantly higher than FIT in detecting all adenomas (48% vs 9.3%), AA (50.8% vs 16.1%) and non-advanced adenomas (44.2% vs 0%). The diagnostic accuracy of m3 could be further enhanced by combining with a panel of fecal microbial markers composing of Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc), Clostridium hathewayi (Ch) for CRC (82.3%) and adenomas (64.2%). We hypothesized that the combination of these 4 bacterial gene markers (known as M3) is more sensitive than FIT in detecting colorectal advanced neoplasia.
Interventions
- Diagnostic test Fecal immunochemical test (FIT)
A kind of stool test
Primary outcome measures
- Sensitivity of bacterial gene markers panel (M3) [Time frame: 1 month]
- Sensitivity of FIT/FOBT [Time frame: 1 month]
Secondary outcome measures (12)
- Sensitivity of M3 for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers [Time frame: 1 month]
- Sensitivity of FIT/FOBT for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers [Time frame: 1 month]
- Sensitivity of FIT/FOBT for advanced adenomas [Time frame: 1 month]
- Sensitivity of M3 for advanced adenomas [Time frame: 1 month]
- Sensitivity of FIT/FOBT for all adenomas [Time frame: 1 month]
- Sensitivity of M3 for all adenomas [Time frame: 1 month]
- Sensitivity of FIT/FOBT for sessile serrated lesions (SSL) [Time frame: 1 month]
- Sensitivity of M3 for sessile serrated lesions (SSL) [Time frame: 1 month]
- Specificity [Time frame: 1 month]
- Positive predictive value (PPV) [Time frame: 1 month]
- Negative predictive value (NPV) [Time frame: 1 month]
- Overall diagnostic accuracy [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- They require elective colonoscopy for colorectal cancer screening or polyp surveillance, or investigation of symptoms (e.g. anemia, change of bowel habit, abdominal pain);
- Aged ≥18 years old;
- Written informed consent obtained.
Exclusion criteria
- Contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);
- Contraindication to polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);
- Known colorectal cancer or adenoma for staged procedure;
- Previous colonic resection;
- Personal history of colorectal cancer;
- Personal history of polyposis syndrome;
- Personal history of inflammatory bowel disease;
- Known pregnancy or lactation;
- Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Hong Kong
Identifiers
NCT: NCT05405673 · 2022.170