Investigation of whether relapsed disease detected upon routine surveillance imaging of pediatric patients with solid tumors is associated with superior outcomes compared to that detected by clinical evaluation
Raya Saab
rs88@aub.edu.lb
PED.RS.17
Ongoing
Clinical Research - Outcomes Research and Health Services Research
No
Collaborators
Farah Lakkis, MD
Coordinators
Lama Zahreddine
lz08@aub.edu.lb
Extension:
8152
Conditions and Keywords
Routine Surveillance Imaging for detection of recurrence of extracranial solid tumors versus change in clinical status
solid tumor; recurrence; outcome
Study Design
Health Services Research
N/A: Not Applicable
Retrospective
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
Eligibility and IRB
Both
Min:
0
Max:
18
Yes
No
Substantial progress has been made in the last couple of decades for the treatment of malignant tumors in children. The improvement in overall survival among various tumors and different age groups validates the importance of looking toward a better quality of life among survivors. Current follow-up guidleines for children with cancer recommend imaging of the primary tumor site and possible sites of metastases, at regular intervals for the first 2 years after end of treatment, then at longer intervals until 5 years off therapy, the definition of “cure”. This is due to the theory that a proper imaging regimen should enable early detection of any recurrence in the site of primary tumor or distant metastases and therefore allows the opportunity for early treatment. However, there is no definitive evidence that early detection of relapse is associated with a better outcome, especially in solid tumors where most relapsed disease is associated with poor long term outcome. In addition, frequent imaging may carry significant risk of increased radiation exposure, as well as the high cost of modalities, and even false positive results that carries a risk of further invasive procedures as well as psychological consequences to the patient and to the family.
Therefore we propose a retrospective review among the survivors of solid tumors at the Children’s Cancer Institute at AUBMC, to investigate whether routine imaging after end of treatment contributes to the rate of detection of relapse and to assess the impact of early versus late detection on overall survival of patient.
Specific aim(s):
•To assess the impact of routine surveillance imaging after end of treatment, on detection of relapse in children with extra-cranial solid tumors
•To compare the outcome of patients with relapse detected on routine surveillance imaging, to that in patients whose relapse was detected due to symptom-based evaluation.
•To estimate the risk/benefit ratio of early detection in relapse and effect of overall survival taking into consideration the risk of radiation exposure, cost, false positive results and procedure complications.
Inclusion criteria: patients < 18 years with extracranial solid tumors s/p end of treatment with relapse of their primary tumor ( Ewing sarcoma, Osteosarcoma, Hodgkins and non-Hodgkins Lymphoma, Ewing Sarcoma)
Exclusion: Patients still under initial treatment
Patients that ended treatment but not having follow up at CCCL
Patients with intracranial tumors and hematological malignancy
The follow-up surveillance is done according to the treatment protocol. Subjects will be identified via a retrospective review of medical records with a discharge diagnosis of Lymphoma, Neuroblastoma, Wilms tumor, Osteosarcoma, and Ewing Sarcoma that had a complete remission period.
Patients will not be contacted or recruited to participate in this study.
Data will be abstracted from the medical records and recorded in a standardized hard copy data sheet .
Data will be obtained about basic demographic characteristics (age, gender, type of tumor, date of completion of treatment). Median follow-up duration is over 5 years.
Patient with relapse will be identified according to the mode of detection, date, site of recurrence and treatment of recurrence. Also the following data Number and results of investigations, radiation exposure, false positive imaging, and overall survival will be recorded. The overall survival is deined as timing of relapse detection to last visit/ death with each method of detection. Time to relapse is defined as time from the date of completion of treatment to the date of relapse.
All the CCCL patients that meet the inclusion criteria are included in the study. Data will be retrospectively collected from the medical records.
Inclusion criteria: patients < 18 years with extracranial solid tumors s/p end of treatment with relapse of their primary tumor ( Ewing sarcoma, Osteosarcoma, Hodgkins and non-Hodgkins Lymphoma, Ewing Sarcoma)
Exclusion: Patients still under initial treatment
Patients that ended treatment but not having follow up at CCCL
Patients with intracranial tumors and hematological malignancy