UMIN-CTR Clinical Trial

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