Acute Lymphoblastic LeukemiaNCT07483749
HEM-SURVIVE: Structuralized Follow-up for Childhood Hematological Malignancy Survivors
An observational study of Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by The Children's Hospital of Zhejiang University School of Medicine at 3 sites in China.
Trial summary
This study aims to construct a structuralized follow-up model for survivors of childhood hematological malignancies in China. Using a multicenter prospective cohort design, it will identify the burden and risk factors of late effects. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoma
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- 25 Mar 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Long-term survivors of childhood hematological malignancies (including ALL, AML, and lymphoma) who have completed primary treatment for at least 12 months and are in complete remission (CR).
Who may be able to join
- Diagnosed with childhood hematological malignancies (ALL, AML, Lymphoma, etc.), Completed primary treatment for ≥12 months.
- Age 1-21 years.
- Capable of completing follow-up and data collection.
- Informed consent signed.
Who cannot join
- Severe organ failure preventing follow-up.
- Major genetic or systemic diseases affecting growth/organ function.
- Expected poor compliance or refusal to participate.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Children's hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jing ying Zhang, MD, 86-15968103802, zhangjy423@zju.edu.cn
Tian Xia, MD, 86-15267035696, xiatian0604@zju.edu.cn
Hangzhou Children's Hospital
Hangzhou, Zhejiang, 310014
Jing Huang, MD, 86-15968103802, zhangjy423@zju.edu.cn
Tian Xia, MD, 86-15267035696, xiatian0604@zju.edu.cn
Affiliated Women and Children's Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Jian hua Feng, MD, 86-15968103802, zhangjy423@zju.edu.cn
Tian Xia, MD, 86-15267035696, xiatian0604@zju.edu.cn
About this study
Official title: A Multicenter Prospective Study on Structuralized Follow-up Model Construction and Late Effect Burden of Childhood Hematological Malignancy Survivors (HEM-SURVIVE)
This study aims to construct a structuralized follow-up model for survivors of childhood hematological malignancies in China. Using a multicenter prospective cohort design, it will identify the burden and risk factors of late effects. The study hypothesizes that a standardized follow-up path managed by an electronic platform will improve follow-up compliance and reduce the missed diagnosis rate of late effects.
Read the detailed description
This multicenter, prospective cohort study is designed to evaluate the effectiveness of a structuralized follow-up model (HEM-SURVIVE) for childhood hematological malignancy survivors in China. Currently, follow-up practices lack a standardized pathway. This study will enroll 400 eligible survivors (aged 1-21 years) and assign them into two cohorts: the structured follow-up mode (utilizing risk stratification, standardized examination packages, MDT clinics, and a dedicated mobile APP) and the conventional follow-up mode. The study aims to accurately assess the burden of late effects (such as cardiovascular events, endocrine disorders, and secondary malignancies) and to determine whether the structured electronic pathway improves patient compliance and early detection rates compared to routine empirical follow-up over a 36-month period.
- Keywords
- Survivorship, Late Effects, Follow-up Model,, Risk Stratification
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Leukemia
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 |
|---|---|---|
| HEM-SURVIVE Structured Follow-up Mode | Implementation of a structured follow-up system based on exposure-oriented risk stratification (four levels: Minimal, Standard, High, and Ultra-high risk). It includes standardized examination packages (A, A+, B, and C), multidisciplinary (MDT) survivor clinics, and digital management via the HEM-SURVIVE APP. | |
| Conventional Follow-up Mode | Routine follow-up practices currently used in China. Examination projects are determined empirically by the attending physician and family, which lacks a unified path and systematic proactive monitoring. Key examinations for late effects are often triggered only after symptoms appear. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe late-effect composite endpoint.
The incidence of grade 3-5 chronic health conditions, including severe cardiovascular events (e.g., heart failure), new-onset diabetes, pathological fractures, severe cognitive/psychological impairment, and second primary malignancies.
Measured: From the date of enrollment to the end of follow-up (up to 36 months).
Compliance rate of the structured follow-up mode.
The percentage of participants who complete the scheduled follow-up visits and examinations according to their assigned risk level. The target compliance rate is ≥80%.
Measured: Throughout the study period (24-36 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start25 Mar 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, Hangzhou Children's Hospital
- Responsible party
- Principal investigator, zhangjingying, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483749
- Sponsor's protocol ID
- 2026-IRB-0014-P-01
- Status last verified
- Dec 2025
- First submitted
- 2 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study on Structuralized Follow-up Model Construction and Late Effect Burden of Childhood Hematological Malignancy Survivors (HEM-SURVIVE)
- ClinicalTrials.gov ID
- NCT07483749
- Acronym / sponsor ID
- 2026-IRB-0014-P-01
- Keywords
- Survivorship, Late Effects, Follow-up Model,, Risk Stratification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, Hangzhou Children's Hospital
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Mar 2026 (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 construct a structuralized follow-up model for survivors of childhood hematological malignancies in China. Using a multicenter prospective cohort design, it will identify the burden and risk factors of late effects. The study hypothesizes that a standardized follow-up path managed by an electronic platform will improve follow-up compliance and reduce the missed diagnosis rate of late effects.
Detailed description
This multicenter, prospective cohort study is designed to evaluate the effectiveness of a structuralized follow-up model (HEM-SURVIVE) for childhood hematological malignancy survivors in China. Currently, follow-up practices lack a standardized pathway. This study will enroll 400 eligible survivors (aged 1-21 years) and assign them into two cohorts: the structured follow-up mode (utilizing risk stratification, standardized examination packages, MDT clinics, and a dedicated mobile APP) and the conventional follow-up mode. The study aims to accurately assess the burden of late effects (such as cardiovascular events, endocrine disorders, and secondary malignancies) and to determine whether the structured electronic pathway improves patient compliance and early detection rates compared to routine empirical follow-up over a 36-month period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEM-SURVIVE Structured Follow-up Mode | – | –Implementation of a structured follow-up system based on exposure-oriented risk stratification (four levels: Minimal, Standard, High, and Ultra-high risk). It includes standardized examination packages (A, A+, B, and C), multidisciplinary (MDT) survivor clinics, and digital management via the HEM-SURVIVE APP. |
| Conventional Follow-up Mode | – | –Routine follow-up practices currently used in China. Examination projects are determined empirically by the attending physician and family, which lacks a unified path and systematic proactive monitoring. Key examinations for late effects are often triggered only after symptoms appear. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Long-term survivors of childhood hematological malignancies (including ALL, AML, and lymphoma) who have completed primary treatment for at least 12 months and are in complete remission (CR).
Key inclusion criteria (4 listed)
- Diagnosed with childhood hematological malignancies (ALL, AML, Lymphoma, etc.), Completed primary treatment for ≥12 months.
- Age 1-21 years.
- Capable of completing follow-up and data collection.
- Informed consent signed.
Key exclusion criteria (3 listed)
- Severe organ failure preventing follow-up.
- Major genetic or systemic diseases affecting growth/organ function.
- Expected poor compliance or refusal to participate.
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
Incidence of severe late-effect composite endpoint.
Time frame: From the date of enrollment to the end of follow-up (up to 36 months).
The incidence of grade 3-5 chronic health conditions, including severe cardiovascular events (e.g., heart failure), new-onset diabetes, pathological fractures, severe cognitive/psychological impairment, and second primary malignancies.
Compliance rate of the structured follow-up mode.
Time frame: Throughout the study period (24-36 months).
The percentage of participants who complete the scheduled follow-up visits and examinations according to their assigned risk level. The target compliance rate is ≥80%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by The Children's Hospital of Zhejiang University School of Medicine at 3 sites in China.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingying Zhang, MD (+86 571 86670076, zhangjy423@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe late-effect composite endpoint. (time frame: From the date of enrollment to the end of follow-up (up to 36 months).). 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 19 Mar 2026.