UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032399
Receipt number R000036952
Scientific Title Laparoscopic para-aortic lymphadenectomy for endometrial cancer stage I, II
Date of disclosure of the study information 2018/05/01
Last modified on 2020/04/27 09:08:02

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Basic information

Public title

Laparoscopic para-aortic lymphadenectomy for endometrial cancer stage I, II

Acronym

LPAND

Scientific Title

Laparoscopic para-aortic lymphadenectomy for endometrial cancer stage I, II

Scientific Title:Acronym

LPAND

Region

Japan


Condition

Condition

Endometrial cancer stage I, II

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of laparoscopic para-aortic lymphadenectomy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Operative time, Intra-operative blood loss, Hospital stay, Recavery time, Perioperative complication

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Laparoscopic para-aortic lymphadenectomy

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)type II cancer of stage IA
2)stage IB or II
3)Cases of 1) or 2) diagnosed after hysterectomy
4)Cases with good general condition
5)Cases with informed consent

Key exclusion criteria

1)Cases more than 80yearas or less than 20 years
2)Cases requiring the morceration to retrieve the specimen
3)Cases with extra-uterine involvement or lymph node metastasis
4)Cases with double cancer
5)Cases without the appropriation

Target sample size

3


Research contact person

Name of lead principal investigator

1st name Nao
Middle name
Last name Suzuki

Organization

St. marianna University School of Medicine

Division name

Obstetrics and Gynecology

Zip code

216-8511

Address

Sugao 2-16-1, Miyamae-ku, Kawasaki

TEL

044-977-8111

Email

nao@marianna-u.ac.jp


Public contact

Name of contact person

1st name Imari
Middle name
Last name Deura

Organization

St. marianna University School of Medicine

Division name

Obstetrics and Gynecology

Zip code

216-8511

Address

Sugao 2-16-1, Miyamae-ku, Kawasaki

TEL

044-977-8111

Homepage URL


Email

imari@marianna-u.ac.jp


Sponsor or person

Institute

St. marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

St. marianna University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. marianna University School of Medicine

Address

Sugao 2-16-1, Miyamae-ku, Kawasaki

Tel

044-977-8111

Email

k-sienbu.mail@marianna-u.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

2018 Year 05 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

Suspended

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB

2018 Year 04 Month 20 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 26 Day

Last modified on

2020 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036952


Research Plan
Registered date File name
2020/04/27 LPAND実施計画書第2版20181112.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name