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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014554', 'term': 'Urination'}], 'ancestors': [{'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples, blood samples, mid-stream urine samples, optional rectal swab samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-10-10', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of obtaining longitudinal blood, urine and stool samples', 'timeFrame': 'From enrolment until 12 months post treatment', 'description': 'Feasibility of obtaining longitudinal blood, urine and stool samples from patients with newly diagnosed prostate cancer undergoing standard of care radiotherapy.\n\nSamples will be collected 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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiotherapy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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).', 'detailedDescription': '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.\n\nThe 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.\n\nEligible 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:\n\n1. stool sample\n2. blood sample (40mls) delegated nurse or research nurse.\n3. mid-stream urine sample\n4. optional rectal swab\n5. quality of life health questionnaire\n\n4-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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed patients with prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, aged ≥ 18; no upper age limit and able to give informed consent.\n* Newly diagnosed patients with, histologically confirmed, localised, intermediate to high-risk prostate cancer (T2b -T4a N0 M0).\n* Patients to be treated with prostate radical radiotherapy IMRT (60Gy in 20# with curative intent) 4-week regimen.\n* Performance status - ECOG 0-2.\n\nExclusion Criteria:\n\n* Had received systemic antibiotics (intravenous, intramuscular, or oral) within 2 months before enrolment.\n* Had received cytotoxic or immunosuppressive therapies within 6 months of enrolment, including chemotherapy or immunotherapy.\n* Had consumed large doses of commercial probiotics (greater or equal to 108 CFU per day) within 12 months of enrolment (such as Actimint®, CranProBio®, ImmunoProBio®, among others).\n* Patients with diagnosed inflammatory bowel disease or coeliac disease\n* Patients with previous colorectal cancer\n* Patients who have undergone colectomy (total or subtotal)\n* Patients with a history of diverticulitis (uncomplicated diverticular disease permitted)'}, 'identificationModule': {'nctId': 'NCT06640959', 'acronym': 'CRIBS', 'briefTitle': 'Chronic Radiation Induced Bowel Toxicity Study', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'Chronic Radiation Induced Bowel Toxicity Study (CRIBS)', 'orgStudyIdInfo': {'id': 'CFTsp225'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Procedure - blood, urine and stool sample collection', 'type': 'PROCEDURE', 'description': 'Samples will be collected (blood, urine, stool and optional rectal swab) at baseline (prior to the start of radiotherapy), weekly during radiotherapy for 4 weeks, 6-8 weeks and 12 weeks from start of radiotherapy, and at 6-month and 12-month follow-up appointments'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'Greater Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Catherine Trigwell', 'role': 'CONTACT', 'email': 'catherine.trigwell@manchester.ac.uk', 'phone': '01613066027'}], 'facility': 'Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'PR2 9HT', 'city': 'Preston', 'state': 'Lancashire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Claire Searle', 'role': 'CONTACT', 'email': 'claire.searle@lthtr.nhs.uk', 'phone': 'claire.searle@lthtr.nhs.uk'}], 'facility': 'Lancashire Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}], 'centralContacts': [{'name': 'Lois Gardner, PhD', 'role': 'CONTACT', 'email': 'lois.gardner@manchester.ac.uk', 'phone': '01612008863'}, {'name': 'Eleanor Cheadle, PhD', 'role': 'CONTACT', 'email': 'eleanor.j.cheadle@manchester.ac.uk', 'phone': '01612008863'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}, {'name': 'Lancashire Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}