Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-05 @ 6:09 PM
Study NCT ID:
NCT06640959
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Radiation Induced Bowel Toxicity Study
Sponsor:
The Christie NHS Foundation Trust
Organization:
Study Overview
Official Title:
Chronic Radiation Induced Bowel Toxicity Study (CRIBS)
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRIBS
Brief Summary:
In the UK over 22,000 people undergo pelvic radiotherapy treatment per year, for several types of cancers including prostate cancer. The investigators want to investigate whether there are any differences in the bacteria in the bowel in patients with prostate cancer and whether these change during treatment.
The aim of this study is to analyse the bacteria from the stool of patients undergoing radiotherapy for prostate cancer. The investigators will also look for any changes in the urine, blood and using rectal swabs that might be a surrogate for what is happening in the gut at the same time. They will collect food frequency/ food diary information for each patient alongside health questionnaires.
The investigators aim to recruit approximately 50 patients diagnosed with prostate cancer due to undergo radiotherapy over a two year period. Patients will be recruited across 2 sites (Rosemere Cancer Centre, Lancashire Teaching Hospitals Trust and The Christie NHS Foundation Trust).
The aim of this study is to analyse the bacteria from the stool of patients undergoing radiotherapy for prostate cancer. The investigators will also look for any changes in the urine, blood and using rectal swabs that might be a surrogate for what is happening in the gut at the same time. They will collect food frequency/ food diary information for each patient alongside health questionnaires.
The investigators aim to recruit approximately 50 patients diagnosed with prostate cancer due to undergo radiotherapy over a two year period. Patients will be recruited across 2 sites (Rosemere Cancer Centre, Lancashire Teaching Hospitals Trust and The Christie NHS Foundation Trust).
Detailed Description:
This is a prospective, translational study which aims to investigate the radiation induced immunological changes in the bowel mucosa, blood and urine, and the role of the microbiota in acute and late bowel toxicity.
The investigators aim to recruit 50 patients newly diagnosed with (histologically confirmed) localised, intermediate to high-risk prostate cancer (T2b -T4a N0 M0), who are due to undergo standard of care radical radiotherapy (Intensity modulated radiotherapy (IMRT)) (60Gy in 20# with curative intent) 4-week regimen.
Eligible patients who have consented to the study will provide the following samples at baseline (prior to the start of radiotherapy), weekly during radiotherapy for 4 weeks, 6-8 weeks and 12 from the start of radiotherapy, and at 6-month and 12-month follow-up appointments:
1. stool sample
2. blood sample (40mls) delegated nurse or research nurse.
3. mid-stream urine sample
4. optional rectal swab
5. quality of life health questionnaire
4-day diet diaries will be completed by the patients in the 4 days prior to providing their baseline stool samples and at follow-up appointments (6-8 weeks, 6 months, 12 months).
The investigators aim to recruit 50 patients newly diagnosed with (histologically confirmed) localised, intermediate to high-risk prostate cancer (T2b -T4a N0 M0), who are due to undergo standard of care radical radiotherapy (Intensity modulated radiotherapy (IMRT)) (60Gy in 20# with curative intent) 4-week regimen.
Eligible patients who have consented to the study will provide the following samples at baseline (prior to the start of radiotherapy), weekly during radiotherapy for 4 weeks, 6-8 weeks and 12 from the start of radiotherapy, and at 6-month and 12-month follow-up appointments:
1. stool sample
2. blood sample (40mls) delegated nurse or research nurse.
3. mid-stream urine sample
4. optional rectal swab
5. quality of life health questionnaire
4-day diet diaries will be completed by the patients in the 4 days prior to providing their baseline stool samples and at follow-up appointments (6-8 weeks, 6 months, 12 months).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: