Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058395) titled 'Prediction of chemosensitivity testing for clinical efficacy with patient-derived cancer stem cells; an observational study' on July 7.
Study Type:
Observational
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - Colorectal cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - We are developing a research protocol for a drug sensitivity test method that can best predict the therapeutic effect of chemotherapy regimens including irinotecan in actual clinical practice for patients using an in vitro model established by culturing patient-derived colorectal cancer spheroids. The purpose of this study is to prospectively verify whether the developed protocol can actually predict the therapeutic effect of chemotherapy regimens in patients.
Basic objectives2 - Bio-equivalence
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Patients with colorectal cancer scheduled to undergo chemotherapy at Kyoto University Hospital, Kochi University Hospital, Kansai Medical University Hospital, Osaka Medical and Pharmaceutical University Hospital, Kurume University Hospital, and Nippon Medical School Hospital
2.Informed consent forms for clinical research related to the establishment of cancer spheroids using colorectal cancer tissues were obtained from research collaborators at Kyoto University Hospital, Kochi University Hospital, Kansai Medical University Hospital, Osaka Medical and Pharmaceutical University Hospital, Kurume University Hospital, and Nippon Medical School Hospital. The cases in which spheroid culture models were established or are planned to be established in this study
Key exclusion criteria - 1. Cases where treatment efficacy cannot be assessed using RECIST
2. Other cases deemed ineligible for this study by the principal investigator and researcher
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2024 Year 05 Month 15 Day
Date of IRB - 2024 Year 05 Month 16 Day
Anticipated trial start date - 2024 Year 07 Month 10 Day
Last follow-up date - 2027 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066760
Disclaimer: Curated by HT Syndication.
