A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor

NCT ID: NCT05024331

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2021-08-12

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.

Conditions

Pediatric Solid Tumor

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pediatric physicians

Assigned Interventions

1. Prediction of the first date of recovery period with given data about chemotherapy of pediatric patients who diagnosed solid tumor at Samsung medical center during 2010-2018

2. Sees the result of the prediction algorithm.

3. Change or maintain their prediction values.

4. Participate in the usability questionnaires.

No interventions assigned to this group

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Samsung Medical Centre

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2021-02-059

Identifier Type: -

Identifier Source: org_study_id