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Hematology/Oncology Research Studies: Open for Enrollment | Date: 06/23/19 |
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| NCT#/Phase: | N/A N/A |
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| IRB#: | 2019-003 |
| Description: | Osteosarcoma survivors will be recruited either directly from their previous enrollment on two COG therapeutic trials, COG AOST0331 and CCG7921 (aka INT0133 or POG9351) or from eligible, comparably treated patient population. Under a separate, non-COG mechanism, controls will be identified and recruited through address-based sampling. Subjects will complete questionnaires and provide blood, saliva, and semen samples through a mail protocol. Blood samples will be analyzed for testosterone, FSH, LH, Inhibin B; genomic DNA extracted from saliva and assessed for host genetic variation in metabolism of chemotherapeutic drugs; and sperm DNA will be assayed using genome-wide methylated DNA immunoprecipitation followed by next generation sequencing. The assembled team and consortium brings together multi-disciplinary expertise in urology, andrology, oncology, epidemiology, biostatistics, and epigenomics. Completion of the proposed research will be a major step towards informing male childhood and AYA cancer |
| Inclusion: | Eligible individuals must be male osteosarcoma survivors without a systematically treated relapse or subsequent malignancy, between the ages of 18-50 years old. Patients must have previously received treatment on AOST0331 or CCG7921 (a.k.a. INT0133 and POG9351) or received upfront therapies, which included cisplatin, with or without ifosfamide, and have completed treatment more than 2 years ago. Patients must be able to speak, read and write in English, French or Spanish. |
| Enrollment Status: | Open for enrollment |
| Sponsor: | Children's Oncology Group |
| Principal Investigator(s): | Carla Golden, MD |
| Contact(s): | Christine Ho (510-428-3885 x 2609) Diane Olzewski (510-428-3885 x 3246) |
| Study Link: | # |