Clinical trial · Observational
Oral & Faecal Microbiota Analysis in Patients With Rectal Cancer Requiring Pre-operative Therapy Before Surgery, & Correlation With Response
Oral & Faecal Microbiota Analysis in Patients With Rectal Cancer Requiring Pre-operative Therapy Before Surgery, & Correlation With Response. (The MicrobRect Study).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rectal cancer is a common pathology which is treated by a multimodal approach. Those tumours in the rectum that are locally advanced are treated with neoadjuvant chemoradiotherapy before an operation. This aims to reduce the size of the tumour and increase the change of a complete resection. The degree of shrinkage of a rectal cancer to pre-operative treatment is influenced by the immune system. In some other cancers there is evidence that the bacteria living in our mouth \& in the large bowel influence the way the body responds a cancer. In this study patients with rectal cancer requiring radiotherapy before surgery will be asked to give samples of saliva \& bowel motions before chemoradiotherapy \& again before surgery. These samples will have the type and number of bacteria analysed, as well as levels of key metabolic products of these bacteria. The results will be compared with the response, as assessed by the pathologist using standard criteria, of the rectal to the radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 16srRNA pyrosequencing analysis of microbiota of saliva and faeces | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Rectal cancer patients
- interventionNames
- Diagnostic Test: 16srRNA pyrosequencing analysis of microbiota of saliva and faeces
Primary outcomes (1)
- measure
- 16s rRNA pyrosequencing analysis of microbial flora of rectal cancer patients
- timeFrame
- 1 year
- description
- The microbial flora of the saliva and faeces of patients will be analysed at two time points. 1. before neoadjuvant chemoradiotherapy and 2. prior to surgery. This will be 16SrRNA pyrosequencing analysis to plot the microbial flora of each sample
Secondary outcomes (1)
- measure
- Categorisation of microbial flora against response to neoadjuvant chemoradiotherapy
- timeFrame
- 1 year
- description
- The pathology resection specimen will be divided into four categories in terms of response to neoadjuvant chemoradiotherapy. 1. complete response, 2. good partial, 3, minimal and 4. complete response. These groupings will be used to analyse if there are any differences in microbial flora which may be able to predict for response to therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with a locally advanced rectal cancer (defined as CRM threatening on MRI scans) in whom neoadjuvant chemoradiotherapy has been offered before consideration of curative resection * must be able to consent to inclusion in project Exclusion Criteria: * Anyone who does not consent for inclusion * Any non rectal adenocarcinoma * Early rectal cancers that do not require neoadjuvant therapy * Patients presenting as an emergency with an obstructing rectal cancer requiring an early resection * Patients who are treated with short course radiotherapy alone rather than long course chemoradiotherapy
References
Publications (0)
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