Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04523038
Status:
RECRUITING
Last Update Posted:
2020-11-25
First Post:
2020-08-19
Brief Title:
Nordic Cystectomy Study II - Albumin
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Nordic Cystectomy Study II - Low Preoperative Albumin Levels Predicting Postoperative Complications in Radical Cystectomy
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-Alb
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 first sub-study is to validate low albumin levels as a predictor of complications after RC The cut-off for low albumin has been 35 mgl across the studies This could be a very cost-effective biomarker but currently its relevance is limited by lack of proper prospective validation studies
The primary end-point in the Albumin sub-study is the 90-day major Clavien Dindo 3-5 complication rate The secondary end-points include total 90-day complication Clavien 1-5 and 90-mortality rate Clavien 5 for all patients and complication rate during NAC for patients receiving 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 first sub-study is to validate low albumin levels as a predictor of complications after RC The cut-off for low albumin has been 35 mgl across the studies This could be a very cost-effective biomarker but currently its relevance is limited by lack of proper prospective validation studies
The primary end-point in the Albumin sub-study is the 90-day major Clavien Dindo 3-5 complication rate The secondary end-points include total 90-day complication Clavien 1-5 and 90-mortality rate Clavien 5 for all patients and complication rate during NAC for patients receiving chemotherapy
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