UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024302
Receipt number R000027988
Scientific Title Analysis of circulating tumor cells(CTCs) and clinical significance of CTCs; human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial
Date of disclosure of the study information 2016/10/19
Last modified on 2016/10/18 20:13:31

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Basic information

Public title

Analysis of circulating tumor cells(CTCs)
and clinical significance of CTCs; human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial

Acronym

Analysis of circulating tumor cells in the
clinical study of ANP administration for lung cancer surgery (JANP study) (Subanalysis of JANP study)

Scientific Title

Analysis of circulating tumor cells(CTCs)
and clinical significance of CTCs; human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial

Scientific Title:Acronym

Analysis of circulating tumor cells in the
clinical study of ANP administration for lung cancer surgery (JANP study) (Subanalysis of JANP study)

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To detect circulating tumor cells(CTCs) and reveal the clinical significance of CTCs for JANP study (human atrial natriuretic peptide for reducing the incidence of postoperative cancer recurrence in patients with completely resected non-small cell lung cancer)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The presence of circulating tumor cells (CTCs)
their morphological characteristics and clinicopathological character, overall survival and disease-free survival,

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: Lung cancer surgery with hANP treatment [Patients in the hANP group receive human ANP (0.025 microgram/kg/min for 3 days), which is started more than two hours before surgery]

Interventions/Control_2

B: Surgery alone

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

Preoperative criteria
1. Non-small cell lung cancer is suspected.
2. Thin-section CT fulfills the proportion of maximum diameter of the tumor itself to consolidation is more than 0.25.
3. It's possible to perfom the complete resection including mediastinal lymph node dissection.
4. Patient without simultaneous or metachronous (within the past 5 years) double cancers.
5. Aged more than 20 years
6. Performance status of 0-2.
7. Sufficient organ functions.
8. All patients gave written informed consent

Key exclusion criteria

1. Thin-section CT fulfills the proportion of maximum diameter of the tumor itself to consolidation is less than 0.25.
2. Patient with active the other concurrent malignant diseases.
3. Women during pregnancy or breast-feeding.
4. Psychosis.
5. Systemic steroids or immunosuppressive agents medication.
6. Uncontrollable infectious disease, autoimmune disease, or the other severe comorbidities.
7. History of right ventricular infarction.
8. Severe hypotension
9. Other conditions judged ineligible by physician

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Kangawa/Meinoshin Okumura

Organization

National Cerebral and Cardiovascular Center Research Institute/Osaka University Graduate School of Medicine

Division name

Biochemistry/General Thoracic Surgery

Zip code


Address

5-7-1, Fujishiro-dai, Suita-city, Osaka 565-8565, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka 565-0871, Japan

TEL

06-6833-5012

Email

kangawa@ri.ncvc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Soichiro Funaki

Organization

Osaka University Graduate School of Medicine

Division name

General Thoracic Surgery

Zip code


Address

2-2 (L5), Yamadaoka, Suita-City, Osaka 565-0871, Japan

TEL

06-6879-3152

Homepage URL


Email

funaki@thoracic.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Shionogi & Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

大阪大学医学部附属病院(大阪府)
大阪府立成人病センター(大阪府)
国立病院機構刀根山病院(大阪府)
大阪府立呼吸器・アレルギー医療センター(大阪府)
北海道大学病院(北海道)
山形大学医学部附属病院(山形県)
山形県立中央病院(山形県)
東京大学医学部附属病院(東京都)
神戸大学医学部附属病院(兵庫県)
国立がん研究センター東病院(千葉県)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 19 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

2015 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 15 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

2016 Year 10 Month 05 Day

Last modified on

2016 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027988


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name