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

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 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

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

Value
https://center6.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