Novel Method of Assessing Urologic and Gastrointestinal Cancer Risk

JRCT ID: jRCTs061220051

Registered date:30/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer, Bladder cancer, Renal cancer, Colon cancer
• Date of first enrollment: 30/08/2022
• Target sample size: 90
• Study type: Interventional
• Intervention(s): 5-ALA phosphate 150 mg as single dose (1 capsule 150 mg once or 2 capsules 75 mg once)

Outcome(s)

• Primary Outcome: Simple quantification method of cut-off values, sensitivity, specificity, positive predictive value, and negative predictive value of urinary coproporphyrin level

Secondary Outcome

(i) Cut-off values, sensitivity, specificity, positive predictive value, and negative predictive value using ROC curve of porphyrin metabolic products by high performance liquid chromatography (HPLC)
(ii) Differences in urinary coproporphyrin levels between cancer and non-cancer patients using the simple assay
(iii) Difference in the amount of porphyrin metabolic products by HPLC between cancer and noncancer subjects

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Urologic and gastrointestinal cancer patients: Group 1
All of the following criteria must be met in order to participate in this study
(i) Cancer patients aged 20 years or older (regardless of gender)
(ii) Patients diagnosed with the cancer types in this study (prostate, renal, bladder, or colorectal cancer) and scheduled for robotic-assisted laparoscopic surgery or laparoscopic surgery..
(iii) Patients who have not received high-concentration vitamin C therapy, 5-ALA combined treatment (e.g., heat, radiation, or other phototherapy) in the period one month prior to urine collection.
(iv) Patients who can stop taking supplements, drinking alcohol, smoking, etc. on the day of urine
collection
(v) Patients who have given written consent to participate in this study.

Cancer-free subjects: Group 2
All of the following criteria must be met in order to
participate in this study
(i) Subjects must be at least 20 years of age and h
ave not been diagnosed with cancer in the past 5
years (regardless of gender).
(ii) Subjects who can stop taking supplements,
drinking alcohol, smoking, etc. on the day of urine
collection.
(iii) Subjects who have given written consent to pa
rticipate in this study.

Exclude criteria

Urologic and gastrointestinal cancer patients: Group 1
If any one of the following criteria applies to you, you are not eligible to participate in this study.
(i) Patients with a history of hypersensitivity to 5-ALA or porphyria
(ii) Patients with a history or diagnosis of porphyria
(iii) Patients who must be administered drugs known to cause photosensitivity or foods containing S
t. John's Wort (St. John's wort) on the day of urine collection.
(iv) Pregnant women or patients of childbearing potential or lactating mothers.
(v) Patients with serious cardiovascular, pulmonary, hepatic, or renal disease, who are undergoing tre
atment or are at risk for such diseases.
(vi) Patients participating in other clinical trials
(vii) Patients who are considered to have problems with compliance with 5-ALA medication
(viii) Patients who may have problems complying with urine collection procedures
(ix) Other patients who are judged to be inappropriate for inclusion in the study by the phy
sician's judgment.

Cancer-free subjects: Group 2
If any of the following criteria apply to you, you are not eligible to participate in this study.
(i) Subjects with a history of cancer
(ii) Subjects with a history of hypersensitivity to 5-ALA or porphyria
(iii) Subjects with a history or diagnosis of porphyria
(iv) Subjects who must be administered drugs known to cause photosensitivity or foods containing S
t. John's Wort on the day of urine collection.
(v) Pregnant women or subjects who may become pregnant or who are lactating.
(vi) Subjects with, undergoing treatment for, or assumed to be at risk for, serious cardiovascular, pul
monary, hepatic, or renal disease
(vii) Subjects participating in other clinical trials.
(viii) Subjects who are considered to have problems with compliance with 5-ALA medication
(ix) Subjects who may have problems complying with urine collection procedures
(x) Other subjects deemed unsuitable for inclusion in the study by the physician's judgment.

Related Information

• Primary Sponsor: Inoue Keiji
• Source(s) of Monetary Support: SBI Pharmaceuticals Co., Ltd