Colorectal Cancer Clinical Trial
— (SCoViDS)Official title:
Scottish Vitamin D Intervention Study
NCT number | NCT04868227 |
Other study ID # | 2014/0058 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 28, 2014 |
Est. completion date | July 11, 2016 |
Verified date | April 2021 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
AIMS To identify the underlying mechanism by which Vitamin D reduces colorectal cancer risk. OBJECTIVES To demonstrate the effects of vitamin D supplementation on serum vitamin D levels. To demonstrate dynamic changes in gene expression in response to vitamin D. To demonstrate the mechanism underlying the gene-environment interaction of vitamin D, susceptibility genetic variants (risk genes) and colorectal cancer.
Status | Completed |
Enrollment | 190 |
Est. completion date | July 11, 2016 |
Est. primary completion date | April 11, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged 16 years or over. - Resident of the United Kingdom Exclusion Criteria: 1. The inability to provide informed consent. 2. Under the age of 16 years. 3. A non-UK resident. 4. Patients who may be at increased risk from rigid sigmoidoscopy: - Individuals who are taking anti-coagulation medication. - Individuals with platelet disease or other bleeding issues. - Individuals with a history of a significant rectal bleed. - Suspected or known bowel perforation - Anal stenosis - Acute peritonitis - Colonic necrosis - Toxic megacolon - Acute severe diverticulitis - Diverticular abscess - Recent colonic surgery - Anal fissure - Severe coagulopathy - Anticoagulant therapy - Severe thrombocytopenia - Severe neutropenia 5. Patients who may be at increased risk from Vitamin D supplementation would not be included in the intervention arm but could still be included in the single sample arm: - Kidney disease - High levels of calcium in the blood - Atherosclerosis - Sarcoidosis - Histoplasmosis - Over-active parathyroid gland (hyperparathyroidism) - Lymphoma - Currently taking thiazide diuretics, digoxin or other cardiac glycosides - Known allergy to nuts ( as peanut oil contained within vitamin D preparations) - Female subjects of child bearing age who are not taking effective contraception during the period of the trial 6. Patients in whom vitamin D levels may be unpredictable - Individuals already established on supplementary Vitamin D. - Individuals recently returned to the UK from an overseas holiday. - Individuals who have recently lived abroad. - Patients on anti-epileptic medication |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Western General Hospital | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | Cancer Research UK, Medical Research Council |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GENE EXPRESSION | RECTAL MUCOSA GENE EXPRESSION | AT BASELINE | |
Primary | GENE EXPRESSION CHANGE | RECTAL MUCOSA GENE EXPRESSION | AFTER 6 WEEK'S SUPPLEMENTATION | |
Primary | GENE EXPRESSION CHANGE | RECTAL MUCOSA GENE EXPRESSION | AFTER 12 WEEK'S SUPPLEMENTATION | |
Secondary | VITAMIN D STATUS | 25-hydroxy-vitamin D (25-OHD) level | AT BASELINE | |
Secondary | VITAMIN D STATUS CHANGE | 25-hydroxy-vitamin D (25-OHD) level | AFTER 6 WEEK'S SUPPLEMENTATION | |
Secondary | VITAMIN D STATUS CHANGE | 25-hydroxy-vitamin D (25-OHD) level | AFTER 12 WEEK'S SUPPLEMENTATION |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |