Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04523025
Status:
RECRUITING
Last Update Posted:
2020-11-25
First Post:
2020-08-19
Brief Title:
Nordic Cystectomy Study I - Neutrophil-lymphocyte Ratio NLR
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Nordic Cystectomy Study I - Prospective Validation of NeutrophilLymphocyte Ratio as Predictor of Bladder Cancer Survival Risk After Radical Cystectomy for Bladder Cancer
Status:
RECRUITING
Status Verified Date:
2020-11
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:
NorCys-NLR
Brief Summary:
Around 7200 cases of Muscle Invasive Bladder Cancer are diagnosed annually in the Nordic countries combined Muscle Invasive Bladder Cancer is an aggressive disease and it is linked with high mortality rates The golden standard of treatment is radical cystectomy RC the surgical removal of the bladder and radical removal of lymph nodes in the pelvis In addition to surgical treatment and especially in cases where the tumour invades tissues surrounding the bladder or lymph nodes chemotherapy is recommended Chemotherapy can be administered before or after surgery in a neoadjuvant NAC or adjuvant setting AC Although most patients recover well from surgery there are significant risks regarding radical cystectomy The greatest challenges in planning the treatment are making individual risk assessments and prognosis for the treated patients Neoadjuvant chemotherapy is also insufficiently used and it is hard to predict how the tumour responds to chemotherapy
The purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other Nordic countries Sweden Denmark Iceland and Norway The collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to RC and prediction of oncological outcome after RC The study is divided into three sub-studies The second sub-study is on the preoperative neutrophil-lymphocyte ratio NLR Some studies suggest that NLR might be a predictor of oncological outcome of BC after RC In addition NLR has been suggested to correlate with NAC response and outcome after NAC and RC The used cut-off value for NLR has varied between 226-30
Patients will be allocated into two groups low NLR ratio NLR3 and high NLR ratio NLR3 The lab test will be retrieved before RC at the time of routine clinical laboratory testing for all patients and also before the initiation of NAC for patients planned to have chemotherapy The primary end-point is bladder-cancer specific survival and and secondary endpoints include progression-free and overall survival
The purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other Nordic countries Sweden Denmark Iceland and Norway The collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to RC and prediction of oncological outcome after RC The study is divided into three sub-studies The second sub-study is on the preoperative neutrophil-lymphocyte ratio NLR Some studies suggest that NLR might be a predictor of oncological outcome of BC after RC In addition NLR has been suggested to correlate with NAC response and outcome after NAC and RC The used cut-off value for NLR has varied between 226-30
Patients will be allocated into two groups low NLR ratio NLR3 and high NLR ratio NLR3 The lab test will be retrieved before RC at the time of routine clinical laboratory testing for all patients and also before the initiation of NAC for patients planned to have chemotherapy The primary end-point is bladder-cancer specific survival and and secondary endpoints include progression-free and overall survival
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