AI-Assisted Whole-Course Management for Medication Safety and Healthcare Burden in Advanced Solid Tumors: A Prospective Controlled Study
NCT07917351, Not applicable, Recruiting, Tianjin Medical University Second Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | AI-Assisted Whole-Course Management for Medication Safety and Healthcare Burden in Advanced Solid Tumors: A Prospective Controlled Study | ClinicalTrials.gov |
| NCT number | NCT07917351 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 420 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Tianjin Medical University Second Hospital | ClinicalTrials.gov |
| Conditions | Digital Health, Artificial Intelligence (AI) | ClinicalTrials.gov |
| Interventions | Oncology Intelligent Management Software, Conventional Offline Follow-up Group | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of any-grade adverse events | Within 24 months of enrollment. | Proportion of participants experiencing any antineoplastic-related adverse event, graded by NCI CTCAE 5.0. | ClinicalTrials.gov |
| Primary | Incidence of severe adverse events (CTCAE grade ≥3) | Within 24 months of enrollment | Proportion of participants experiencing grade ≥3 bone marrow suppression, gastrointestinal events, rash, liver injury, or other CTCAE grade ≥3 events. | ClinicalTrials.gov |
| Secondary | Emergency department visit rate due to anticancer treatment-related adverse events | 12 months after enrollment | Proportion of participants with at least one emergency department visit due to an anticancer treatment-related adverse event during follow-up. Data source: medical records and participant-reported events confirmed by the study site. | ClinicalTrials.gov |
| Secondary | 30-day readmission rate related to anticancer treatment-related adverse events | 12 months after enrollment; each readmission assessed within 30 days after discharge | Among participants with at least one hospitalization related to an anticancer treatment-related adverse event, proportion readmitted within 30 days after discharge. Each discharge is followed for 30 days. | ClinicalTrials.gov |
| Secondary | Incidence of anticancer drug dose reduction due to adverse events | 12 months after enrollment | Proportion of participants requiring at least one reduction in anticancer drug dose due to an adverse event, as documented in the medical record. | ClinicalTrials.gov |
| Secondary | Incidence of treatment delay due to adverse events | 12 months after enrollment | Proportion of participants with at least one anticancer treatment cycle delayed or temporarily interrupted due to an adverse event. | ClinicalTrials.gov |
| Secondary | Incidence of missed anticancer doses | 12 months after enrollment | Among participants receiving oral anticancer therapy, proportion with at least one missed dose during follow-up, based on app check-in records (intervention group) or self-report/outpatient records (control group). | ClinicalTrials.gov |
| Secondary | Median time to adverse event recovery | From adverse event onset to recovery, assessed up to 12 months after enrollment | Median time from onset of an eligible adverse event to recovery of symptoms and/or laboratory abnormality to baseline or CTCAE grade ≤1, estimated using Kaplan-Meier methods. Adverse events are graded by NCI CTCAE 5.0. | ClinicalTrials.gov |
| Secondary | Monthly mean number of missed oral anticancer doses | Monthly for 12 months after enrollment | Mean number of missed oral anticancer doses per participant per month, calculated from app check-in records (intervention group) or self-report/outpatient records (control group). | ClinicalTrials.gov |
| Secondary | Protocol adherence rate among clinical trial participants (exploratory) | 12 months after enrollment | Among participants concurrently enrolled in a clinical trial, proportion who complete protocol-specified treatment cycles and scheduled assessments without major protocol deviation, as documented by the site. | ClinicalTrials.gov |
| Secondary | Protocol deviation incidence among clinical trial participants (exploratory) | 12 months after enrollment | Among participants concurrently enrolled in a clinical trial, proportion with at least one protocol deviation, classified by type and relationship to the digital management intervention. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)