UMIN-CTR Clinical Trial

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