Pediatric Solid TumorNCT05024331
A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor
An observational study of Pediatric Solid Tumor, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Solid Tumor
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jul 2021to 12 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: a physician who is working at Samsung Medical Center as a pediatric doctor
Who may be able to join
- physician who is working at Samsung Medical Center as a pediatric doctor
- A person who voluntarily agrees to participate in the study
Who cannot join
- Those who disagree with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor : Data Collection and Model Validation
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.
Read the 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
- Keywords
- oncology, prediction model, hematological recovery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of algorithm
primary outcome is the difference between result of algorithm and prediction values of doctors.
total number of pediatric patients who performed chemotherapy and high-capacity chemotherapy at Samsung Medical Center in 2019-2020 - (Exclusion such as insufficient data or death) +10 reliability check questions expected to be approximately 100 questions The test based on data consisting of blood test results from approximately 100 patients, is recorded in anticipation of the first date (recovery date) of a day when ANC levels over 500 last more than 3 days.
Measured: This clinical trial is conducted in one day, and the Survey is conducted after completing the test using data from 99 pediatric patients.
A quantitative study on usability
We would like to ask 17 questions to identify the user's thoughts on AI and how they affect change of opinion. The following are examples are as follows:
Do you think you can easily adapt to new technologies or programs? Do you value subjective thoughts and experiences over other people's opinions in your work? Do you tend to browse information online when making decisions during work? Apart from this study, are you positive about the use of predictive models in clinical trials? Do you think the items and information in the given data are sufficient to predict the values you want to predict?
Measured: This clinical trial is conducted in one day, and the Survey is conducted after completing the test using data from 99 pediatric patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start30 Jul 2021
- Primary completion30 Jul 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid TumorStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024331
- Sponsor's protocol ID
- 2021-02-059
- Status last verified
- Jul 2021
- First submitted
- 10 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor : Data Collection and Model Validation
- ClinicalTrials.gov ID
- NCT05024331
- Acronym / sponsor ID
- 2021-02-059
- Conditions
- Pediatric Solid Tumor
- Keywords
- oncology, prediction model, hematological recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- a physician who is working at Samsung Medical Center as a pediatric doctor
Key inclusion criteria (2 listed)
- physician who is working at Samsung Medical Center as a pediatric doctor
- A person who voluntarily agrees to participate in the study
Key exclusion criteria (1 listed)
- Those who disagree with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy of algorithm
Time frame: This clinical trial is conducted in one day, and the Survey is conducted after completing the test using data from 99 pediatric patients.
primary outcome is the difference between result of algorithm and prediction values of doctors. total number of pediatric patients who performed chemotherapy and high-capacity chemotherapy at Samsung Medical Center in 2019-2020 - (Exclusion such as insufficient data or death) +10 reliability check questions expected to be approximately 100 questions The test based on data consisting of blood test results from approximately 100 patients, is recorded in anticipation of the first date (recovery date) of a day when ANC levels over 500 last more than 3 days.
A quantitative study on usability
Time frame: This clinical trial is conducted in one day, and the Survey is conducted after completing the test using data from 99 pediatric patients.
We would like to ask 17 questions to identify the user's thoughts on AI and how they affect change of opinion. The following are examples are as follows: Do you think you can easily adapt to new technologies or programs? Do you value subjective thoughts and experiences over other people's opinions in your work? Do you tend to browse information online when making decisions during work? Apart from this study, are you positive about the use of predictive models in clinical trials? Do you think the items and information in the given data are sufficient to predict the values you want to predict?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Solid Tumor, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of algorithm (time frame: This clinical trial is conducted in one day, and the Survey is conducted after completing the test using data from 99 pediatric patients.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.