UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043722 |
|---|---|
| Receipt number | R000049921 |
| Scientific Title | The role of 18F-FDG PET/CT scan compared to CT-scan alone for lymph node staging before radical cystectomy in patients with bladder cancer |
| Date of disclosure of the study information | 2021/03/24 |
| Last modified on | 2021/04/06 00:58:43 |
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Basic information
Public title
The role of 18F-FDG PET/CT scan compared to CT-scan alone for lymph node staging before radical cystectomy
Acronym
RPETLNRC
Scientific Title
The role of 18F-FDG PET/CT scan compared to CT-scan alone for lymph node staging before radical cystectomy in patients with bladder cancer
Scientific Title:Acronym
RPETLNRCBC
Region
| Asia(except Japan) |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluate the diagnostic value of PET-CT scan, compared with CT scan alone for preoperative LN staging of Bladder cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the diagnostic value of PET-CT scan, compared with CT scan alone for preoperative LN staging of bladder cancer (sensitivity, specificity, PPV, NPV)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
All patients had both PET-CT and CT abdomen and pelvis to assess for pelvic LN involvement before RC
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients with non-muscle and muscle-invasive bladder cancer (NMIBC&MIBC) undergoing RC were considered for radical cystectomy during the study period
-All patients had both PET-CT and CT abdomen and pelvis to assess for pelvic LN involvement before RC.
-Patients included in this study underwent standard CT imaging < 3 weeks before PET-CT
Key exclusion criteria
patients who had received neoadjuvant chemotherapy
Had <10 LNs removed at lymphadenectom
have non-urothelial carcinoma variants on histology
patients with visceral metastasis
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Mohamad |
| Middle name | |
| Last name | Abou Chakra |
Organization
Al zahraa hospital
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
0096171613732
mohamedabouchakra@hotmail.com
Public contact
Name of contact person
| 1st name | Mohamad |
| Middle name | |
| Last name | Moussa |
Organization
Al Zahraa Hospital
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
009613964412
Homepage URL
mohamadamoussa@hotmail.com
Sponsor or person
Institute
Al Zahraa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Al Zahraa Hospital
Address
Beirut, Lebanon
Tel
009611843752
uroprog@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
300
Results
Results date posted
| 2021 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 07 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049921
