Diagnostische nauwkeurigheid van een panel van bacteriële genmarkers (M3) voor colorectale geavanceerde neoplasie (M3-PRO)
Een prospectieve cross-sectionele studie om de diagnostische nauwkeurigheid van een panel van bacteriële genmarkers (M3) voor colorectale geavanceerde neoplasie te beoordelen
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
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Hong Kong, Hongkong
- Prince of Wales Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Subjects with average risk of colorectal neoplsia requring screening/surveillance colonoscopy
Beschrijving
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);
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_ONLY
- Tijdsperspectieven: CROSS_SECTIONAL
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Colorectal neoplasia screening/surveillance cohort
Subjects with average risk of colorectal neoplasias requiring screening/surveillance colonoscopy |
A kind of stool test
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sensitivity of bacterial gene markers panel (M3)
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of M3 among those with one of more advanced neoplasia detected in the index colonoscopy. |
1 month
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|
Sensitivity of FIT/FOBT
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of FIT among those with one of more advanced neoplasia detected in the index colonoscopy. |
1 month
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sensitivity of M3 for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of M3 among those with early-stage (stage 1) or invasive (stage 2-4) colorectal cancers detected in the index colonoscopy. |
1 month
|
|
Sensitivity of FIT/FOBT for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of FIT among those with early-stage (stage 1) or invasive (stage 2-4) colorectal cancers detected in the index colonoscopy. |
1 month
|
|
Sensitivity of FIT/FOBT for advanced adenomas
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of FIT among those with one or more advanced adenomas detected in the index colonoscopy. |
1 month
|
|
Sensitivity of M3 for advanced adenomas
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of M3 among those with one or more advanced adenomas detected in the index colonoscopy. |
1 month
|
|
Sensitivity of FIT/FOBT for all adenomas
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of FIT among those with all advanced adenomas detected in the index colonoscopy. |
1 month
|
|
Sensitivity of M3 for all adenomas
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of M3 among those with all advanced adenomas detected in the index colonoscopy. |
1 month
|
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Sensitivity of FIT/FOBT for sessile serrated lesions (SSL)
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of FIT among those with SSLs detected in the index colonoscopy. |
1 month
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Sensitivity of M3 for sessile serrated lesions (SSL)
Tijdsspanne: 1 month
|
The proportion of subjects with true positive results of M3 among those with SSLs detected in the index colonoscopy. |
1 month
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Specificity
Tijdsspanne: 1 month
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The proportion of true negative results of M3/FOBT/FIT among those with no adenoma detected in colonoscopy |
1 month
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Positive predictive value (PPV)
Tijdsspanne: 1 month
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The ratio of subjects truly diagnosed as positive to all those who had positive test results |
1 month
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Negative predictive value (NPV)
Tijdsspanne: 1 month
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The ratio of subjects truly diagnosed as negative to all those who had negative test results |
1 month
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Overall diagnostic accuracy
Tijdsspanne: 1 month
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The proportion of correctly classified subjects among all subjects |
1 month
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|
Microbiota changes in subjects with adenomas or normal findings after polypectomy
Tijdsspanne: 1 month
|
Microbiota change measured by qPCR or metagenomic sequencing |
1 month
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2022.170
Plan Individuele Deelnemersgegevens (IPD)
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