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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034365
Receipt No. R000039108
Scientific Title Study regarding long-term prognosis of the cases recruited in "Prospective Study Investigating Laparoscopic Surgery for Locally Advanced Rectal Cancer with Evaluation of CRM and TME quality: PRODUCT trial"
Date of disclosure of the study information 2018/10/03
Last modified on 2018/10/24

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Basic information
Public title Study regarding long-term prognosis of the cases recruited in "Prospective Study Investigating Laparoscopic Surgery for Locally Advanced Rectal Cancer with Evaluation of CRM and TME quality: PRODUCT trial"
Acronym Study regarding long-term prognosis of the cases recruited in "PRODUCT trial"
Scientific Title Study regarding long-term prognosis of the cases recruited in "Prospective Study Investigating Laparoscopic Surgery for Locally Advanced Rectal Cancer with Evaluation of CRM and TME quality: PRODUCT trial"
Scientific Title:Acronym Study regarding long-term prognosis of the cases recruited in "PRODUCT trial"
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the association between the results of CRM and TME and long-term prognosis, thereby assessing oncological feasibility of the laparoscopic or robot-assisted surgery for rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year local recurrence rate
Key secondary outcomes 3-year overall survival, 3-year recurrence free survival

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Rectal cancer (less than or equal to 12 cm from the anal verge)
cStage II, III
Scheduled for laparoscopic surgery or robot-assisted surgery
Age greater than or equal to 20 years
Key exclusion criteria The depth of invasion is cT4b
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Takemasa
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code
Address 291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo-shi, Hokkaidou
TEL 011-611-2111
Email jpcrm@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Hamabe
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code
Address 291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo-shi, Hokkaidou
TEL 011-611-2111
Homepage URL
Email ahamabe@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University, Department of Surgery, Surgical Oncology and Science
Institute
Department

Funding Source
Organization Sapporo Medical University, Department of Surgery, Surgical Oncology and Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Oita University
Cancer Institute Hospital
Kitasato University
Kyoto University
National Cancer Center Hospital East
Saitama Medical University International Medical Center
Nagoya University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 10 Month 03 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
Results
Results date posted
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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study.
Evaluating the association between the results of CRM and TME and long-term prognosis.

Management information
Registered date
2018 Year 10 Month 03 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039108

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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