Unique ID issued by UMIN | UMIN000045114 |
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Receipt number | R000051486 |
Scientific Title | Frequent post-operative monitoring of colorectal cancer using individualized ctDNA validated by multi-regional molecular profiling |
Date of disclosure of the study information | 2021/08/15 |
Last modified on | 2021/08/10 17:43:57 |
Frequent post-operative monitoring of colorectal cancer using individualized ctDNA validated by multi-regional molecular profiling
Circulating tumor DNA monitoring in colorectal cancer
Frequent post-operative monitoring of colorectal cancer using individualized ctDNA validated by multi-regional molecular profiling
Circulating tumor DNA monitoring in colorectal cancer
Japan |
colorectal cancer
Gastrointestinal surgery |
Malignancy
YES
The aim of this study is to elucidate clinical validities of circulating tumor DNA (ctDNA) monitoring by digital PCR using individual tumor-specific mutations in post-operative survey of colorectal cancer patients.
Others
The aim of this study is to elucidate whether frequent tumor burden monitoring with ctDNA of a small number of individual tumor-specific mutations using digital PCR provides clinically useful information in post-operative survey of colorectal cancer patients. With longitudinal ctDNA monitoring during treatment in addition to routine surveillance, ctDNA dynamics and clinical relapse by conventional surveillance modalities are compared if ctDNA provides useful information such as the early detection of relapse.To verify the effect of tumor genetic and proteomic heterogeneity in regard to circulating tumor DNA (ctDNA) by multiregional sequencing and proteomic analysis of primary colorectal cancer.
Exploratory
Not applicable
ctDNA dynamics and clinical relapse by conventional surveillance modalities are compared if ctDNA provides useful information on the early detection of relapse.
1. Association of pre-treatment ctDNA detection and tumor genetic and proteomic heterogeneity
2. ctDNA monitoring and disease-free confirmation
3. Pretreatment ctDNA detection and overall survival
4. Pretreatment ctDNA detection and disease free survival
5. ctDNA dynamics and treatment efficacy
6. Specificity and sensitivity of ctDNA test for relapse
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Pre-operative colorectal cancer patients with clinical Stage II or higher. 1. Patients must have given written an informed consent
2. Histologically confirmed colorectal cancer
1. Patients who do not wish to pursue standard of care therapy 2. patients who are considered ineligible for enrolling the study by a principal investigator or sub-investigator
150
1st name | Satoshi |
Middle name | S. |
Last name | Nishizuka |
Iwate Medical University Institute for Biomedical Sciences
Division of Biomedical Research and Development
0283695
1-1-1 Idaidori, Yahaba, Iwate
0196515111
snishizu@iwate-med.ac.jp
1st name | Takeshi |
Middle name | |
Last name | Iwaya |
Iwate Medical University Hospital
Department of Surgery
0283695
2-1-1 Idaidori, Yahaba, Iwate
0196137111
tiwaya@iwate-med.ac.jp
Iwate Medical University
Iwate Medical University
Other
Iwate Medical University
1-1-1 Idaidori, Yahaba, Iwate
0196515111
snishizu@iwate-med.ac.jp
NO
2021 | Year | 08 | Month | 15 | Day |
Partially published
https://www.nature.com/articles/s41416-021-01266-4
12
Founder mutations, defined as a mutation that is present in all regions of the tumor in a binary manner, were identified in 12/14 tumors. In contrast, truncal mutations, which are the first mutations that occur prior to divergence of branches in the phylogenetic tree using variant allele frequency as continuous variables, were identified in 12/14 tumors. Most founder and truncal mutations exhibited high VAFs and more likely to be detected as ctDNA.
2021 | Year | 08 | Month | 09 | Day |
Enrolling by invitation
2015 | Year | 11 | Month | 01 | Day |
2015 | Year | 12 | Month | 21 | Day |
2016 | Year | 03 | Month | 11 | Day |
2025 | Year | 12 | Month | 31 | Day |
In addition to mutation and protein expression profiles, gene expression profiling of primary colorectal cancer will be analyzed.
2021 | Year | 08 | Month | 10 | Day |
2021 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051486
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