Oral & Faecal Microbiota Analysis in Patients With Rectal Cancer Requiring Pre-operative Therapy Before Surgery, & Correlation With Response

NCT04601727 | Completed

• 1 other identifier: 2-014-20
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 16s rRNA pyrosequencing analysis of microbial flora of rectal cancer patients

  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

  1 year

Secondary Outcomes (1)

• Categorisation of microbial flora against response to neoadjuvant chemoradiotherapy

  1 year

Study Arms (1)

Rectal cancer patients

Diagnostic Test: 16srRNA pyrosequencing analysis of microbiota of saliva and faeces

Interventions

16srRNA pyrosequencing analysis of microbiota of saliva and faeces DIAGNOSTIC_TEST

No intervention in this study

Rectal cancer patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Locally advanced rectal cancer patients suitable for neoadjuvant chemoradiotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

16srRNA analysis of faeces and saliva before and after neoadjuvant chemoradiotherapy

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Defecation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 26, 2020
• Study Start: June 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: May 16, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

GB (1)