Unique ID issued by UMIN | UMIN000034830 |
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Receipt number | R000038705 |
Scientific Title | Prospective observational study to evaluate clinical utility of FoundationObe CDx |
Date of disclosure of the study information | 2018/11/10 |
Last modified on | 2021/05/12 09:02:06 |
Prospective observational study to evaluate clinical utility of FoundationObe CDx
Prospective observational study to evaluate clinical utility of FoundationObe CDx
Prospective observational study to evaluate clinical utility of FoundationObe CDx
Prospective observational study to evaluate clinical utility of FoundationObe CDx
Japan |
gastrointestinal cancer, rare cancer and cancer of unknown primary
Medicine in general |
Malignancy
YES
To determine the rate of actionable/druggable cancer genomic alterations in patients with stage III/IV gastrointestinal cancer, rare cancer and cancer of unknown primary using panel-based genomic sequencing test
Efficacy
Detection rate of actionable/druggable cancer genomic alterations using FoundationOne CDx
Observational
16 | years-old | <= |
Not applicable |
Male and Female
1. Patients with histologically diagnosed stage III/IV(UICC-TNM 8th)gastrointestinal cancer, rare cancer and cancer of unknown primary
2. Written informed consent
3. Formalin Fixed Paraffin Embedded(FFPE)cancer tissue is available for pathological diagnosis, and remaining cancer tissue is enough for genomic sequencing test as well.
4. Age >= 16 years
5. Previously untreated cancer patients. The following patients will be allowed: patients treated with oral anticancer drugs as adjuvant therapy and patients with sufficient FFPE tissue obtained before the start of anticancer drugs.
6. Patients with recurrent disease inside irradiation field will be excluded. (If tissue is available from a recurrent tumor outside the irradiation field, the patient can be included.)
7. For a recurrence case, it has to be less than 3 years after surgery.
1. Patients without available tumor tissue
2. Patients judged to be inappropriate for the study by investigators
200
1st name | |
Middle name | |
Last name | Manabu Muto |
Kyoto University Hospital
Clinical Oncology
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
075-751-3518
fmi_kuhp@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Tomohiro Kondo |
Kyoto University Hospital
Clinical Oncology
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
075-751-3518
fmi_kuhp@kuhp.kyoto-u.ac.jp
Kyoto University
Chugai Pharmaceutical Co.,Ltd.
Profit organization
NO
2018 | Year | 11 | Month | 10 | Day |
Unpublished
Completed
2018 | Year | 11 | Month | 07 | Day |
2018 | Year | 11 | Month | 08 | Day |
2018 | Year | 11 | Month | 12 | Day |
2021 | Year | 11 | Month | 07 | Day |
observational study
2018 | Year | 11 | Month | 09 | Day |
2021 | Year | 05 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038705
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