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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043722
Receipt No. 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

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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
Email 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
Email mohamadamoussa@hotmail.com

Sponsor
Institute Al Zahraa Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049921

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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