Patient-derived Xenograft (PDX) Modeling to Test Drug Response for High-grade Osteosarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03358628|
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment|
|Osteosarcoma||Other: Molecular Profiling & In Vivo drug testing in PDX|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Patient-derived Xenograft (PDX) Modeling to Test Drug Response for High-grade Osterosarcoma|
|Estimated Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2025|
Osteosarcoma patients with metastatic relapsed or unresectable progressive disease (total n= up to 20) following resection of the primary lesion and adjuvant chemotherapy.
Other: Molecular Profiling & In Vivo drug testing in PDX
Molecular profiling of host tumour sample and PDX will be performed and analyzed by an expert panel. In vitro drug testing using organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo PDX drug testing results will be made, if available.
- Measure of drug sensitive PDX to a panel of drugs as a predictor of clinical response in matched host [ Time Frame: up to 2 years ]Sensitivity measured by tumor growth inhibition (>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358628
|Contact: Tingting Ren, PhDemail@example.com|
|Contact: Yidan Zhang, MDfirstname.lastname@example.org|
|Principal Investigator:||Wei Guo, MD, PhD||Peking University People's Hospital|