Clinical trial NCT05024331: A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor
Official title: A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor : Data Collection and Model Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Solid Tumor
Keywords: oncology
prediction model
hematological recovery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a physician who is working at Samsung Medical Center as a pediatric doctor

Brief summary: This study aims to compare and evaluate the predicted values of the participants, and the algorithm predicted values of ANC level reduction periods after high-capacity chemotherapy in pediatric solid tumor patients. The participants are pediatricians who voluntarily participate in this study and consent to this study.

Detailed description: n pediatric patients with solid tumors, chemotherapy for radical treatment is generally based on monitoring white blood cells, red blood cells, and platelets with repeated blood tests during treatment due to bone marrow depression.

Early blood culture and experiential intravenous antibiotics are required to prevent progression to sepsis if fever or other infection signs are accompanied by a decrease in absolute neutrophil count (ANC) below 500/mm3. In addition, repeated blood transfusions are needed to keep the appropriate levels constant depending on clinical symptoms in platelet reduction or anemia.

In particular, in the case of high-dose chemotherapy conducted on high-risk tumors, anticancer drugs are given over the dose expected to recover natural bone marrow function to improve the treatment performance of tumors responding to chemotherapy. Moreover, it is challenging to recover naturally after high-dose chemotherapy so that the collected in advanced hematopoietic stem cells are implanted into the patient to support ANC level recovery.

However, despite the transplantation of these self-hematopoietic stem cells, some patients need long-term continuous blood transfusions due to delayed hematological recovery and may need long-term hospitalization to treat accompanying infections and complications.

The researcher developed a model that can predict the suppression and hematological recovery of bone marrow after high-capacity anticancer drugs by analyzing blood tests and blood transfusions repeatedly from the diagnosis of pediatric solid tumors after high-capacity chemotherapy collected from 2000-2018.

Eligibility criteria: Inclusion Criteria:

* physician who is working at Samsung Medical Center as a pediatric doctor
* A person who voluntarily agrees to participate in the study

Exclusion Criteria:

* Those who disagree with the study

Primary outcomes:
measure: accuracy of algorithm
timeFrame: This clinical trial is conducted in one day, and the Survey is conducted after completing the test using data from 99 pediatric patients.
measure: A quantitative study on usability
timeFrame: This clinical trial is conducted in one day, and the Survey is conducted after completing the test using data from 99 pediatric patients.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre
Study officials:
References: