Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04537221
Status:
RECRUITING
Last Update Posted:
2020-11-25
First Post:
2020-08-19
Brief Title:
Nordic Cystectomy Study III - Transfusion
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Nordic Cystectomy Study III - Prospective Validation of Transfusions as a Poor Prognostic Factor 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-Transf
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 Transfusions during RC and the time of hospitalization after the surgery are associated poorer oncological outcome when compared to those patients who do not need transfusions The third study focuses on the oncological outcomes in patients receiving blood transfusions As there are some conflicting reports and the finding is not properly validated we aim to validate the effect of transfusions on survival after RC
The number of transfusions during RC and the time between surgery and discharge from hospital will be recorded Patient cohort will be divided into patients receiving transfusions and not receiving transfusion The primary end point is patients receiving transfusion and its effect on cancer specific mortality at 24 months For patients receiving NAC additional secondary end-point is complete response pT0N0 rate at RC
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 Transfusions during RC and the time of hospitalization after the surgery are associated poorer oncological outcome when compared to those patients who do not need transfusions The third study focuses on the oncological outcomes in patients receiving blood transfusions As there are some conflicting reports and the finding is not properly validated we aim to validate the effect of transfusions on survival after RC
The number of transfusions during RC and the time between surgery and discharge from hospital will be recorded Patient cohort will be divided into patients receiving transfusions and not receiving transfusion The primary end point is patients receiving transfusion and its effect on cancer specific mortality at 24 months For patients receiving NAC additional secondary end-point is complete response pT0N0 rate at RC
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