UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of screening for gynecologic malignancies by measuring urine-blood porphyrin concentration using oral 5-aminolevulinic acid
Title of the study (Brief title)	Efficacy of screening for gynecologic malignancies using 5-ALA
Region	Japan

Condition
Condition	malignant genital tumors benign gynecologic tumors
Classification by specialty	Obsterics and gynecology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	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.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1: >=20 years old Japanese 2: Performance Status 0-1 3: A person who has obtained consent under the voluntary 4: After screening gynecological
Key exclusion criteria	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.
Target sample size	120

Research contact person
Name of lead principal investigator	Mka Mizuno
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
Address	65 Tsuruma-cho, Showa-ku, Nagoya 466-8550
TEL	052-744-2261
Email	mizunomizuno@med.nagoya-u.ac.jp

Public contact
Name of contact person	Mika Mizuno
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
Address	65 Tsuruma-cho, Showa-ku, Nagoya 466-8550
TEL	052-744-2261
Homepage URL
Email	mizunomizuno@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	名古屋大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 08 Month 15 Day
Anticipated trial start date	2012 Year 10 Month 15 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 10 Day
Last modified on	2017 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009902