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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041628
Receipt No. R000047520
Scientific Title A histological cohort study fo assess the adverse events using Adspray in laparoscopic surgery for early uterine endometrial cancer.
Date of disclosure of the study information 2020/09/01
Last modified on 2020/09/01

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Basic information
Public title A histological cohort study fo assess the adverse events using Adspray in laparoscopic surgery for early uterine endometrial cancer.
Acronym Adieu study
Scientific Title A histological cohort study fo assess the adverse events using Adspray in laparoscopic surgery for early uterine endometrial cancer.
Scientific Title:Acronym Adieu study
Region
Japan

Condition
Condition Uterine endometrial cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of using Adspray in Laparoscopic surgery including pelvic lymph node dissection (not including para-aortic lymph node dissection) for early endometrial cancer with presumed advanced stage classification (FIGO2008) stage IA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of postoperative infection within 30 days after surgery
Key secondary outcomes

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
80 years-old >=
Gender Female
Key inclusion criteria 1. Patients with presumed advanced stage classification (FIGO2008) stage IA endometrial cancer who scheduled for laparoscopic hysterectomy including pelvic lymph node dissection (not including para-aortic lymph node dissection).
2. Patients planning to use Adspray
3. ECOG performance Status 0 or 1.
4. Informed written consent is obtained.
Key exclusion criteria 1. Patients scheduled for robot-assisted hysterectomy using da Vinci surgical system.
2. Patients scheduled for surgery without pelvic lymph node dissection.
3. Patients scheduled for para-aortic lymph node dissection.
4. Patients with pelvic infection or infectious diseases requiring treatment.
5. History of obstructive bowel disease.
6. History of pelvic radiation therapy.
7. Patients who are judged to be inappropriate as subject to this study by the physician.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Tsutomu
Middle name
Last name Tabata
Organization Tokyo Women's Medical University
Division name Gynecology
Zip code 162-8666
Address 8-1,Kawadacho,Shinjuku-ku,Tokyo
TEL 03-3353-8111
Email tabata.tsutomu@twmu.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Motohashi
Organization Tokyo Women's Medical University
Division name Gynecology
Zip code 162-8666
Address 8-1,Kawadacho,Shinjuku-ku,Tokyo
TEL 03-3353-8111
Homepage URL
Email sr21det@rb3.so-net.ne.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization TERUMO CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Women's Medical University
Address 8-1,Kawadacho,Shinjuku-ku,Tokyo
Tel 0333538111
Email tabata.tsutomu@twmu.ac.jp

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
2020 Year 09 Month 01 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
2020 Year 05 Month 26 Day
Date of IRB
2020 Year 06 Month 16 Day
Anticipated trial start date
2020 Year 06 Month 16 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, the main purpose is to grasp the adverse events by using Adspray when performing the laparoscopic hysterectomy with pelvic lymph node dissection (without para-aortic lymph node dissection) for endometrial cancer presumed advanced stage classification (FIGO2008) stage IA.
As a comparative control, at the participating facilities of this study, we investigate the information when similar surgery was performed on cases with the same condition as historical control(retrospective observational study), and compare with the results of the prospective observational study.

Management information
Registered date
2020 Year 09 Month 01 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047520

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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