Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058466) titled 'A prospective observational study to evaluate the efficacy of a Cancer Surveillance for children and adolescent/young adults with Li-Fraumeni syndrome' on July 22.

Study Type: Observational

Primary Sponsor: Institute - Japan Children's Cancer Group,(JCCG)

Condition: Condition - Li-Fraumeni syndrome Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - The efficacy of cancer surveillance programme is evaluated by assessing both the detection of early-stage cancer through whole-body MRI and the detection of cancer through cancer surveillance programme. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - 40 years-old > Gender - Male and Female Key inclusion criteria - Individuals who meet all of the following criteria will be eligible for the cancer surveillance programme. (1) Positive TP53 genetic test (in this study or OVUS test in LFS20)or classical criteria a) matching cases. (2) Age 39 or younger at the time of consent (LFS20 participants over the age of 39 are included) (3) ECOG Performance Status(ECOG PS)of 0-2. (4) Individuals who have not developed cancer, or who have developed cancer but have maintained remission for more than one year after completion of treatment. Note: Treatment refers to surgery, radiation therapy, chemotherapy(anticancer drugs), and molecular targeted therapy. (Hormone therapy is permissible during this period) (5) Individuals who have undergone genetic counseling and consented to TP53 genetic testing. (6) Individuals who have obtained written consent. Key exclusion criteria - Individuals who fit any of the following categories will be excluded from the cancer surveillance programme. (1) Women who are pregnant or suspected of being pregnant. (2) Individuals for whom MRI scanning is contraindicated. (3) Individuals who require sedation for MRI scanning. (4) Individuals who are deemed unsuitable for participation in this study by the principal investigator or researchers. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 14 Day Date of IRB - 2025 Year 06 Month 05 Day Anticipated trial start date - 2025 Year 07 Month 28 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066790

Disclaimer: Curated by HT Syndication.