UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045355 |
|---|---|
| Receipt number | R000051790 |
| Scientific Title | A prospective study on prediction of efficacy of preoperative radiochemotherapy for advanced rectal cancer using liquid biops |
| Date of disclosure of the study information | 2021/09/02 |
| Last modified on | 2024/02/01 13:05:59 |
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Basic information
Public title
A prospective study on prediction of efficacy of preoperative radiochemotherapy for advanced rectal cancer using liquid biops
Acronym
A prospective study on prediction of efficacy of preoperative radiochemotherapy for advanced rectal cancer using liquid biops
Scientific Title
A prospective study on prediction of efficacy of preoperative radiochemotherapy for advanced rectal cancer using liquid biops
Scientific Title:Acronym
A prospective study on prediction of efficacy of preoperative radiochemotherapy for advanced rectal cancer using liquid biops
Region
| Japan |
Condition
Condition
Advanced Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is threefold. To evaluate the efficacy of preoperative chemoradiation in patients with locally advanced rectal cancer.
1) To determine whether plasma and urine cell free DNA levels and the presence or absence of RAS and p53 mutations are useful for predicting response in pretreatment liquid biopsy.
2) To evaluate whether cell free DNA levels and mutation allele frequency (MAF) in preoperative chemoradiation, at the end of each course, and in postoperative liquid biopsy are predictive of response to nCRT.
(3) To follow the changes of cell free DNA level and MAF in patients with clinical complete response (cCR) and to examine the relationship with relapse and prognosis.
Translated with www.DeepL.com/Translator (free version)
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation of the dose of ctDNA and exosome DNA during treatment and the survival.
Key secondary outcomes
Correlation between ctDNA and exosome DNA amounts before, during, and after treatment and recurrence-free survival time
Correlation between ctDNA, exosome DNA amount and tumor markers
Correlation between ctDNA, exosome DNA amount, response rate of neoadjuvant chemotherapy (RECIST Ver1.1), and disease control
Correlation between the amount of ctDNA and exosome DNA and the rate of decrease in the SUVmax value of the primary tumor determined by PET-CT examination
Correlation between ctDNA, exosome DNA amount and histological treatment effect (grade based on tumor cell disappearance rate according to Evans criteria)
Correlation between ctDNA, exosome DNA amount and resection rate
ctDNA, exosome DNA amount and radical resection rate (R1 or R0; R1: state with no macroscopic residual cancer, R0: state with no histological residual cancer)
Comparative study of the amount of ctDNA and exosome DNA of the target gene and immunostaining results in surgical resection specimens
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Advanced rectal cancer diagnosed by colonoscopy, CT or MRI imaging
Key exclusion criteria
Patient unable to give consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Matsuda |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8509
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
m07055nt@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Takemoto |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8509
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
Homepage URL
m07055nt@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Research expense
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
Wakayama medical university
Address
811-1 Kimiidera Wakayama, Japan
Tel
0734472300
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 02 | 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
| 2021 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051790
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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