Unique ID issued by UMIN | UMIN000021002 |
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Receipt number | R000024241 |
Scientific Title | BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study |
Date of disclosure of the study information | 2016/03/15 |
Last modified on | 2017/08/15 09:16:48 |
BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study
BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study
BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study
BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study
Japan |
Metastatic colorectal adenocarcinoma
Gastroenterology | Gastrointestinal surgery |
Malignancy
YES
To describe the frequency of BRAF mutation (V600E and non-V600E mutation) using residual samples from the RAS-wild type metastatic colorectal adenocarcinoma, and to clarify the relationships BRAF mutational status, microsatellite instability (MSI), and patient's clinic-pathological characteristics and treatment outcomes.
Others
To describe the frequency of BRAF mutation (V600E and non-V600E mutation)
Describe frequency of BRAF mutations (V600E and non-V600E mutations) in KRAS/NRAS wild-type metastatic colorectal adenocarcinoma.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)The subject has histologically confirmed colorectal adenocarcinoma.
2)The subject has metastatic or locally advanced disease not amendable to curative surgery.
3)The subject must be currently receiving or prior to first-line chemotherapy.
4)The subject is at least 20 years of age at the time of informed consent.
5)The patient has provided singed informed consent prior to any study specific procedures.
1)The subject has other malignancies which affect the patients' survival time.
2)The tumor has previously confirmed RAS mutant or BRAF mutant colorectal cancer.
3)The subject is receiving or panning to concomitant radiotherapy for primary site.
4)The subject is not appropriate for this study due to any other reasons.
1000
1st name | |
Middle name | |
Last name | Hiroya Taniguchi |
Aichi Cancer Center Hospital
Department of Clinical Oncology
Kanokoden 1-1, Chikusa-ku, Nagoya, Aichi, Japan
052-762-6111
h.taniguchi@aichi-cc.jp
1st name | |
Middle name | |
Last name | Hiroya Taniguchi |
Aichi Cancer Center Hospital
Department of Clinical Oncology
Kanokoden 1-1, Chikusa-ku, Nagoya, Aichi, Japan
052-762-6111
h.taniguchi@aichi-cc.jp
Aichi Cancer Center Hospital, Department of Clinical Oncology
Takeda Pharmaceutical Company Limited
Profit organization
NO
2016 | Year | 03 | Month | 15 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 12 | Month | 21 | Day |
2017 | Year | 02 | Month | 01 | Day |
This is a multicenter, observational study to describe frequency of BRAF mutations (V600E and non V600E mutations), which is primary objective in KRAS NRAS wild type metastatic colorectal adenocarcinoma. The subject must have histologically confirmed, unresectabole colorectal adenocarcinoma. The subject must be currently receiving or prior to first-line chemotherapy. The subject has available archival tumor tissue sufficient for submission to the central laboratory.
2016 | Year | 02 | Month | 13 | Day |
2017 | Year | 08 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024241
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