Clinical trial · Observational
Development of Indices Predicting Response to Pre-operative Chemotherapy in Osteosarcoma Patients
Validity Verification of Indices Utilizing TGF-b1, NF-kB, PET/CT, and MRS Predicting Response to Neoadjuvant Chemotherapy in Osteosarcoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to develop indices predicting response to pre-operative chemotherapy in osteosarcoma patients. Histologic response to pre-operative chemotherapy is very important for the ultimate outcome of osteosarcoma patients. Conventional methods such as CT or MRI evaluating tumor response to chemotherapy is not so efficient in tumors like osteosarcoma. Instead, the investigators will test whether blood TGF-b1 levels, PET/CT findings, MRS findings as well as the level of NF-kB expression in tumor tissues can predict chemotherapy response in osteosarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- A
- description
- 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.
Primary outcomes (1)
- measure
- histopathologic necrosis fractions of surgically removed tumor specimen
- timeFrame
- 12-17 weeks after starting chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Karnofsky (over 15 years) or Lansky (less than 15 years) score equal or greater than 50 * Adequate organ functions: * GFR\>60ml/min/1.73m2 * EF\>50% or SF\>28% on echocardiogram * ANC\>1.5 x 10\^9/L * platelet\>100 x 10\^9/L * Obtainment of informed consents from parents/legal guardians and/or patients Exclusion Criteria: * Pregnant or lactating women * Cardiovascular dysfunction * History of previous chemotherapy
References
Publications (0)
Data not yet available