Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02978547
Status:
UNKNOWN
Last Update Posted:
2018-01-18
First Post:
2016-11-02
Brief Title:
The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official Title:
The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
NOT_YET_RECRUITING
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:
Metformin 001
Brief Summary:
This is a single arm non-randomized phase II study of neoadjuvant metformin in resectable PDAC Twenty patients will be enrolled and treated with metformin 500 mg BD for a minimum of 7 days until 2 days prior to surgery Patients will undergo laboratory investigations at baseline prior to surgery and 4-10 weeks after surgery Patients eligible for and consented to the optional MRI substudy will undergo diffusion-weighted MRI 1 to 14 days before surgery
At surgery resected tumour and normal tissue will be collected and banked FFPE specimens will be used for sectioning histological analysis and IHC for Ki67 cell proliferation marker pAMPK ACC targets p53 and mTOR targets apoptotic markers Bax Bcl-2 caspases 3 8 and 9 Fresh frozen tumour and matched normal tissue samples will be used for western blot analysis of insulin and IGF receptors total and activated ERK and Akt and RNAseq analysis Pre-metformin biopsy samples will be retrieved for molecular analysis
Fasting blood samples at baseline and before surgery will be analyzed for glucose and insulin levels Plasma and whole blood will also be processed and banked for circulating tumour DNA analysis Urine samples will be sent for metabolomic profiling
At surgery resected tumour and normal tissue will be collected and banked FFPE specimens will be used for sectioning histological analysis and IHC for Ki67 cell proliferation marker pAMPK ACC targets p53 and mTOR targets apoptotic markers Bax Bcl-2 caspases 3 8 and 9 Fresh frozen tumour and matched normal tissue samples will be used for western blot analysis of insulin and IGF receptors total and activated ERK and Akt and RNAseq analysis Pre-metformin biopsy samples will be retrieved for molecular analysis
Fasting blood samples at baseline and before surgery will be analyzed for glucose and insulin levels Plasma and whole blood will also be processed and banked for circulating tumour DNA analysis Urine samples will be sent for metabolomic profiling
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None