Unique ID issued by UMIN | UMIN000045076 |
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Receipt number | R000049512 |
Scientific Title | Study of usefulness of diagnosis of MALT lymphoma using endocytoscopy before and after treatment |
Date of disclosure of the study information | 2021/08/10 |
Last modified on | 2024/02/13 10:21:36 |
Evaluation of the usefulness of endocytoscopy for diagnosis of gastric MALT lymphoma before and after treatment
MALTEC study
Study of usefulness of diagnosis of MALT lymphoma using endocytoscopy before and after treatment
MALTEC study
Japan |
Gastric MALT lymphoma
Gastroenterology | Hematology and clinical oncology |
Malignancy
NO
To evaluate diagnostic ability of endocytoscopic images in vivo to the histological grade of gastric MALT lymphoma
Efficacy
Diagnostic accuracy of endocytoscopic images by 3 doctors who don't perform endocytoscopy (all images and biopsy)
1:Sensitivity, specificity, positive predictive value, negative predictive value of biopsy with endocytoscopy.
2:Accuracy, sensitivity, specificity, positive predictive value, negative predictive value of biopsy with endocytoscopy by whom perform endocytoscopy.
3:Accuracy of diagnosis of magnified encoscopy.
4:Concordance rate of diagnosis using images of endocytoscopy and magnified endoscopy by three doctors who don't perform endocytoscopy
5:Correlation of numbers of cells and glands in images by using endocytoscopy and magnified endoscopy
6:Cor0relation of numbers of cells and glands in images between endocytoscopy and histopathology.
*We define ECM3 and Wotherspoon grade 4-5 as existing MALT lymphoma.
*We difine ECM1 and GELA pMRD and ChR as remission of MALT lymphoma.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients before treatment of MALT lymphoma and who is scheduled detailed examination and biopsy or patients after initial treatment of MALT lymphoma and who is scheduled detailed examination and biopsy.
Patients who are explained adequately about this research and can understand enough and assume and agree by patient's free will.
Patients that performing endocytoscopy affect after examination and treatment.
Patients who have allergy of methylene blue or crystal violet.
Patients who are forbidden biopsy.
Patients whom researcher estimates inadequate for this research.
20
1st name | Shoko |
Middle name | |
Last name | Ono |
Hokkaido University Hospital
Division of Endoscopy
0608648
Kita14, Nishi5, Kita-Ku, Sapporo
+81-11-716-1161
onosho@med.hokudai.ac.jp
1st name | Marina |
Middle name | |
Last name | Kubo |
Hokkaido University Hospital
Division of Endoscopy
0608648
Kita14, Nishi5, Kita-Ku, Sapporo
+81-11-716-1161
marina.2kb.83@gmail.com
Division of Endoscopy, Hokkaido University Hospital
None
Other
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Kita14, Nishi5, Kita-Ku, Sapporo, Hokkaido, Japan
+81-11-716-1161
crjimu@huhp.hokudai.ac.jp
NO
2021 | Year | 08 | Month | 10 | Day |
Unpublished
Open public recruiting
2021 | Year | 01 | Month | 05 | Day |
2021 | Year | 01 | Month | 28 | Day |
2021 | Year | 01 | Month | 28 | Day |
2026 | Year | 09 | Month | 30 | Day |
2026 | Year | 09 | Month | 30 | Day |
2026 | Year | 09 | Month | 30 | Day |
nothing particular
2021 | Year | 08 | Month | 05 | Day |
2024 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049512
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