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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042003 |
Receipt No. | R000043671 |
Scientific Title | Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer |
Date of disclosure of the study information | 2020/10/05 |
Last modified on | 2020/10/04 |
Basic information | ||
Public title | Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer | |
Acronym | Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer | |
Scientific Title | Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer | |
Scientific Title:Acronym | Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer | |
Region |
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Condition | |||
Condition | Esophageal cancer, Esophago-gastric junctional cancer, Gastric cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | YES |
Objectives | |
Narrative objectives1 | To clarify clinical utility of detecting MRD and monitoring using ctDNA analysis in patients with gastrointestinal cancer who plan to undergo curative treatment. |
Basic objectives2 | Others |
Basic objectives -Others | To evaluate clinical performance of ctDNA analysis. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Correlation between RFS and ctDNA in patients with gastrointestinal cancer who underwent curative treatment (R0/R1 resection). |
Key secondary outcomes |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Esophageal cancer, esophago-gastric junction cancer, gastric cancer by clinical or histological diagnosis
2) Patients who plan to curative treatment 3) Age >= 20 year old. 4) Written informed consent obtained. |
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Key exclusion criteria | 1) Patients with double cancer (excluding early or superficial cancers which can be curatively resected by endoscopic treatment)
2) Any other patients who are regarded as inadequate for study enrollment by principal investigators. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital East | ||||||
Division name | Department of Gastroenterology and Gastrointestinal Oncology | ||||||
Zip code | 277-8577 | ||||||
Address | 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan | ||||||
TEL | 04-7133-1111 | ||||||
takojima@east.ncc.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Cancer Center Hospital East | ||||||
Division name | Department of Gastroenterology and Gastrointestinal Oncology | ||||||
Zip code | 277-8577 | ||||||
Address | 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan | ||||||
TEL | 04-7133-1111 | ||||||
Homepage URL | |||||||
dkotani@east.ncc.go.jp |
Sponsor | |
Institute | National Cancer Center Hospital East |
Institute | |
Department |
Funding Source | |
Organization | National Cancer Center Hospital East |
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 | NCC IRB office |
Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan |
Tel | 03-3542-2511 |
NCC_IRBoffice@ml.res.ncc.go.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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Study design: Observational study |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043671 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |