Study on cancer risk assessment method using 5-aminolevulinic acid

Study on cancer risk assessment method using 5-aminolevulinic acid - cancer risk assessment method using 5-aminolevulinic acid

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039304

Enrollment

400

Registered

2020-01-29

Start date

2018-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer, colon cancer, stomach cancer, breast cancer

Interventions

Oral administration of 5-aminolevulinic acid phosphate 150 mg once at night

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Cancer patients 20 years or older (male, female) 2) Patients diagnosed with the target carcinoma (lung cancer, stomach cancer, colon cancer, breast cancer) 3) Patients who do not have different primary tumors other than the target 4 carcinomas 4) Patients whose target carcinoma is recognized by CT, MRI, ultrasound, etc. 5) Inpatients 6) Patients who have given written consent to participate in this study 7) Patients who have not been treated with high-concentration vitamin C therapy or hyperthermia, radiation, or other phototherapy combined with 5ALA in the period one month before urine collection 8) Patients who can stop drugs, supplements, drinking, smoking, etc. on the day of urine collection

Exclusion criteria

Exclusion criteria: 1) Patients with a history or diagnosis of porphyria 2) Pregnant women or patients who may become pregnant or breastfeeding 3) Patients who have difficulty in filling in the consent form or have problems with the urine collection procedure due to psychiatric complications, etc. 4) Patients with primary tumors other than the target 4 carcinomas 5) Patients who underwent high-concentration vitamin C therapy or treatment with 5-ALA, such as heat, radiation, or other phototherapy, one month before urine collection 6) Patients with severe cardiovascular disease, lung, liver, or kidney disease who are undergoing treatment or are at risk for it 7) Patients who are required to prescribe drugs separately prescribed on the day of urine collection 8) Other patients who are judged inappropriate by the doctor's judgment

Design outcomes

Primary

Measure	Time frame
Analysis of the accuracy of 5-aminolevulinic acid as a cancer risk assessment index	—

Countries

Japan

Contacts

Public ContactYoshikane Yamauchi

Teikyo University School of medicine Department of surgery

yoshikaney@med.teikyo-u.ac.jp03-3964-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026