JPRN-jRCTs061220051招募中2 期
Cancer Risk Assessment Method for Urological and Gastrointestinal Cancers Using 5-Aminolevulinic Acid (5-ALA)
Inoue Keiji0 个研究点目标入组 90 人开始时间: 2022年8月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
- •(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.
排除标准
- •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.
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