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PI left organization and discontinued study
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| Name | Class |
|---|---|
| Alfred I. duPont Hospital for Children | OTHER |
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This study will be performed to evaluate the Clinical Outcomes and Quality of Life after Transarterial Radioembolization with Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults with Liver Tumors. The treatment and techniques used here are well established in adults.
The purpose of this study is to evaluate:
Review of medical records provided by referring institution will be done by the Nemours Liver Tumor Program Team including:
History, Scans-actual imaging required, Path report-slide submission required, Roadmaps, Labs, Other pertinent medical history and records
-Visit to Nemours/AI DuPont Children's Hospital for initial consultation will be arranged by the Nemours Liver Tumor Program Team.
The patient and family will meet with the team including:
Liver transplant surgeon (Dr Dunn), Interventional Radiologist (Dr Aguado), Social worker, Child life specialist, Pediatric oncologist (Dr Gresh - on site, Dr Katzenstein by telemedicine)
All further Chemotherapy Care is coordinated with Nemours Liver Tumor oncologists
-A 2nd visit to AIDHC will occur for TARE-Y90 treatment: The procedure lasts about 2-3 hours. There is no planned admit but possible if any problems occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Evaluation of change of HRQOL survey responses will be performed:
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of Life Assessment | Behavioral | Evaluation of change of HRQOL survey responses will be performed:
The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL) | Evaluation of change of HRQOL survey responses will be performed: -at baseline (time of treatment) The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database | Assessed at baseline/time of treatment |
| Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL) | Evaluation of change of HRQOL survey responses will be performed: - 1 month post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database | Assessed at 1 month post therapy |
| Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL) | Evaluation of change of HRQOL survey responses will be performed: - 6 months post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database | Assessed at 6 months post therapy |
| Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL) | Evaluation of change of HRQOL survey responses will be performed: - 12 months post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database | Assessed at 12 months post therapy |
| Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL) | Evaluation of change of HRQOL survey responses will be performed: - 5 years post-treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database | Assessed at 5 years post therapy |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric and Young adult patients with liver tumors
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| Name | Affiliation | Role |
|---|---|---|
| Howard Katzenstein | Nemours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours-AI duPont Hospital for Children | Wilmington | Delaware | 19803 | United States | ||
| Nemours Children's Specialty Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30406959 | Result | Aguado A, Ristagno R, Towbin AJ, Gupta A, Haberle S, Qi Z, Patel MN, Kukreja KU, Tiao GM, Geller JI. Transarterial radioembolization with yttrium-90 of unresectable primary hepatic malignancy in children. Pediatr Blood Cancer. 2019 Jul;66(7):e27510. doi: 10.1002/pbc.27510. Epub 2018 Nov 8. |
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|
| Transarterial Radioembolization | Radiation | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic
|
|
| Evaluate the efficacy and clinical utility of TARE-Y90 by examining 2 year survival | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic - | Patients will be assessed at 2 years post therapy |
| Evaluate the efficacy and clinical utility of TARE-Y90 by examining 5 year survival | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic | Patients will be assessed at 5 years post therapy |
| Evaluate the efficacy and clinical utility of TARE-Y90 by examining local tumor response | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST). | Patients will be assessed at the end of treatment which is typically 2-4 months following treatment |
| Evaluate the efficacy and clinical utility of TARE-Y90 by examining resection rate | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Resection Rate following treatment | Patients will be assessed at the end of treatment which is typically 2-4 months following treatment. |
| Evaluate the efficacy and clinical utility of TARE-Y90 by examining Transplant rate | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Transplant Rate following treatment | Patients will be assessed at the end of treatment which is typically 2-4 months following treatment. |
| Evaluate the efficacy and clinical utility of TARE-Y90 by examining histologic response | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant | Patients will be assessed at the end of treatment which is typically 2-4 months following treatment. |
| Evaluate the efficacy and clinical utility of TARE-Y90 by examining biologic response | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors | Patients will be assessed at the end of treatment which is typically 2-4 months following treatment. |
| Evaluate the efficacy and clinical utility of TARE-Y90 by examining clinical course | Deliver catheter directed yttrium-90 directly to liver tumors and assess -Review of clinical course post-treatment-rehospitalization rate | Patients will be assessed at the end of treatment which is typically 2-4 months following treatment. |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| ID | Term |
|---|---|
| D018197 | Hepatoblastoma |
| D006528 | Carcinoma, Hepatocellular |
| D012734 | Disorders of Sex Development |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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