UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026853
Receipt number R000030816
Scientific Title A prospective study of fertility preservation surgery after neoadjuvant chemotherapy for early cervical cancer
Date of disclosure of the study information 2017/04/05
Last modified on 2017/04/04 13:55:42

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Basic information

Public title

A prospective study of fertility preservation surgery after neoadjuvant chemotherapy for early cervical cancer

Acronym

Fertility preservation surgery after neoadjuvant chemotherapy

Scientific Title

A prospective study of fertility preservation surgery after neoadjuvant chemotherapy for early cervical cancer

Scientific Title:Acronym

Fertility preservation surgery after neoadjuvant chemotherapy

Region

Japan


Condition

Condition

Cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Validity of fertility preservation surgery
after neoajuvant chemotherapy for cervical cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety of surgery

Key secondary outcomes

Rate of pregnancy


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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

neoadjuvant chemotherapy three cycle
fertility presevation surgery
radical trachelectomy
adjuvant chemotherapy three cycle

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

0 years-old <=

Age-upper limit

40 years-old >

Gender

Female

Key inclusion criteria

Cervical cancer SCC
FIGO Stage 1B1
above two cm under four cm

Key exclusion criteria

Non SCC
distant metastasis LN swelling

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Niikura

Organization

Tohoku University Hospital

Division name

Gynecology

Zip code


Address

Seiryo machi aobaku sendai

TEL

022-717-7254

Email

Niikura@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Tokunaga

Organization

Tohoku University

Division name

gynecology

Zip code


Address

Seiryo machi aobaku sendai

TEL

0227177254

Homepage URL


Email

tokunagahideki@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tohoku 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


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

2017 Year 04 Month 05 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

Preinitiation

Date of protocol fixation

2017 Year 04 Month 04 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 04 Month 04 Day

Last modified on

2017 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030816


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name