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Clinical Trials/JPRN-jRCTs061220051
JPRN-jRCTs061220051
Recruiting
Phase 2

Cancer Risk Assessment Method for Urological and Gastrointestinal Cancers Using 5-Aminolevulinic Acid (5-ALA)

Inoue Keiji0 sites90 target enrollmentAugust 30, 2022

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Inoue Keiji
Enrollment
90
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 30, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Inoue Keiji

Eligibility Criteria

Inclusion 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
  • (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

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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