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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048372
Receipt No. R000055130
Scientific Title Prediction of postoperative complications in digestive organ cancer by cell free DNA measurement
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/13

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Basic information
Public title Prediction of postoperative complications in digestive organ cancer by cell free DNA measurement
Acronym Prediction of postoperative complications in digestive organ cancer by cell free DNA measurement
Scientific Title Prediction of postoperative complications in digestive organ cancer by cell free DNA measurement
Scientific Title:Acronym Prediction of postoperative complications in digestive organ cancer by cell free DNA measurement
Region
Japan

Condition
Condition Digestive organ cancer
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether measurement of perioperative cell free DNA amount and fragment length is useful for predicting postoperative complications in digestive organ cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association of perioperative cell free DNA amount and fragment length with postoperative complications.
Key secondary outcomes 1. Association of perioperative cell free DNA amount and fragment length with clinicopathological factors.
2. Association of perioperative cell free DNA amount and fragment length with operative procedure.
3. Association of perioperative cell free DNA amount and fragment length with recurrence and prognosis.
4. Association of perioperative cell free DNA amount and fragment length with frailty in patients older than 65 years.

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 1. Patients with digestive organ cancer or precancerous lesion requiring standard therapy.
2. 20 years and more at informed consent.
3. Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria 1. Patients whose consent cannot be obtained.
2. Patients whose participation in the trial was judged to be inappropriate by the attending doctor.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Kitahata
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
TEL 073-441-0613
Email yuji-kh@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Nakamura
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
TEL 073-441-0613
Homepage URL
Email y-nakamu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, Second Department of Surgery
Institute
Department

Funding Source
Organization Wakayama Medical University
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 Independent ethics committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
Tel 073-447-2300
Email wa-rinri@wakayama-med.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 和歌山県立医科大学附属病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2022 Year 08 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
2022 Year 04 Month 01 Day
Date of IRB
2022 Year 06 Month 08 Day
Anticipated trial start date
2022 Year 06 Month 08 Day
Last follow-up date
2027 Year 06 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2022 Year 07 Month 13 Day
Last modified on
2022 Year 07 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055130

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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