Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640959
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Chronic Radiation Induced Bowel Toxicity Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Chronic Radiation Induced Bowel Toxicity Study CRIBS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRIBS
Brief Summary:
In the UK over 22000 people undergo pelvic radiotherapy treatment per year for several types of cancers including prostate cancer We 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 We 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 We will collect food frequency food diary information for each patient alongside health questionnaires
We aim to recruit approximately 50 patients diagnosed with prostate cancer due to undergo radiotherapy over a two year period We will recruit patients 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 We 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 We will collect food frequency food diary information for each patient alongside health questionnaires
We aim to recruit approximately 50 patients diagnosed with prostate cancer due to undergo radiotherapy over a two year period We will recruit patients 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
We 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
We 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None