UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048372 |
|---|---|
| Receipt number | 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 22:57:30 |
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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
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
y-nakamu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, Second Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055130
