Unique ID issued by UMIN | UMIN000008890 |
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Receipt number | R000009902 |
Scientific Title | Efficacy of screening for gynecologic malignancies by measuring urine-blood porphyrin concentration using oral 5-aminolevulinic acid |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2017/09/26 19:32:17 |
Efficacy of screening for gynecologic malignancies by measuring urine-blood porphyrin concentration using oral 5-aminolevulinic acid
Efficacy of screening for gynecologic malignancies using 5-ALA
Efficacy of screening for gynecologic malignancies by measuring urine-blood porphyrin concentration using oral 5-aminolevulinic acid
Efficacy of screening for gynecologic malignancies using 5-ALA
Japan |
malignant genital tumors
benign gynecologic tumors
Obstetrics and Gynecology | Adult |
Malignancy
NO
Urinary/serum samples from 3 groups (patients with malignant genital tumor, with benign tumor, healty person) are analyzed for levels of porphyrins. Receiver operating characteristic (ROC) curves are constructed for porphyrins, and the cutoff value which identifies malignant tumor are investigated.
PK,PD
Relation between of urinary/serum porphyrins value and pathological factors in 3 groups (patients with malignant genital tumor, with benign tumor, healty person) . Receiver operating characteristic (ROC) curves are constructed for porphyrins, and the cut-off value to identify malignant tumor.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Diagnosis
Medicine |
measuring urine-blood porphyrin concentration using oral 5-aminolevulinic acid(300mg)
1)50cases, for 3 years
Pre-operative patients with malignant including ovarian cancer, cervical cancer, endometrial cancer.
2)50cases,for 3 years
Pre-operative patients with benign tumor including myoma uteri, chocolate cyst, dermoid tumor, and so on.
20cases, for 3 years
Healthy person(volunteer)
After general health examination, screening gynecological diseases.
20 | years-old | <= |
Not applicable |
Female
1: >=20 years old Japanese
2: Performance Status 0-1
3: A person who has obtained consent under the voluntary
4: After screening gynecological
1)Patients (including tuberculosis activities) uncontrolled infection.
2)Patients with severe anamnesis (Malignant hypertension. With severe congestive heart failure. Severe liver failure. Myocardial infarction within 3 months. End-stage cirrhosis. Poorly controlled diabetes. Severe pulmonary fibrosis. Interstitial pneumonia activity)
3) Allogeneic bone marrow transplantation
4) Patients with severe mental disorders
5)Patients with porphyria or hypersensitivity to porphyrins allergy
6) A gravida, a lactational woman
7) Patients with severe anemia
8)Patients were deemed inappropriate by research investigators
9)Patients with malignant tumor during treatment. cancer patients within 5 years after treatment.
120
1st name | |
Middle name | |
Last name | Mka Mizuno |
Nagoya University Graduate School of Medicine
Department of Obstetrics and Gynecology
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550
052-744-2261
mizunomizuno@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Mika Mizuno |
Nagoya University Graduate School of Medicine
Department of Obstetrics and Gynecology
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550
052-744-2261
mizunomizuno@med.nagoya-u.ac.jp
Nagoya University
Nagoya University
Other
NO
名古屋大学医学部付属病院
2012 | Year | 10 | Month | 01 | Day |
Unpublished
No longer recruiting
2012 | Year | 08 | Month | 15 | Day |
2012 | Year | 10 | Month | 15 | Day |
2017 | Year | 12 | Month | 31 | Day |
2012 | Year | 09 | Month | 10 | Day |
2017 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009902
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