Development of Indices Predicting Response to Pre-operative Chemotherapy in Osteosarcoma Patients
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Validity Verification of Indices Utilizing TGF-b1, NF-kB, PET/CT, and MRS Predicting Response to Neoadjuvant Chemotherapy in Osteosarcoma Patients|
- histopathologic necrosis fractions of surgically removed tumor specimen [ Time Frame: 12-17 weeks after starting chemotherapy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||February 2007|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Study group will be made up of patients hospitalized to National Cancer Center, Korea, aged between 5 and 40 years, and diagnosed with high grade osteosarcoma by histological exam.
In this group, TGF-b1 measurement, PET/CT and MRS examination at diagnosis, after 1st cycle chemotherapy, and 2nd or 3rd chemotherapy (just before surgery) will be made.
In addition, evaluation of NF-kB expression status in tumor specimens at diagnostic biopsy and tumor removing surgery will be done.
The results of above studies will be correlated with the necrosis fractions of the tumor tissues removed by surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686738
|Korea, Republic of|
|National Cancer Center|
|Goyang-si, Gyeonggi, Korea, Republic of|
|Principal Investigator:||Byung-Kiu Park, M.D., Ph.D.||Pediatric Oncology Branch, National Cancer Center, Korea|