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Early identification of asymptomatic malignancy in hospitalized patients with diabetes

Clinical Characteristics and Development of a Risk-Identification Model for Incidentally Detected Malignancy in Patients With Diabetes: A Case–Control Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114517
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

In-hospital asymptomatic malignant tumour case group:None
Group of hospitalised patients with diabetes during their first admission and without malignant tumours:None

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Case Group (Diabetes with Asymptomatic Malignant Tumour Detected During Hospitalisation) Inclusion Criteria: 1. Patients diagnosed with diabetes meeting the criteria of the Chinese Diabetes Prevention and Treatment Guidelines (2024 Edition); 2. Malignant tumours newly identified during current hospitalisation: primarily confirmed by pathology; where pathology is not performed due to objective constraints, diagnosis must be strongly suggested by imaging and confirmed through specialist consultation or multidisciplinary team (MDT) discussion records; 3. Meets "asymptomatic screening" criteria: admission unrelated to tumour-associated symptoms, no definite organ system symptoms at diagnosis; incidentally detected during routine or systematic screening during current hospitalisation; 4. Complete key metabolic and relevant laboratory parameters; Control group (diabetes without in-hospital detection of malignancy) Inclusion criteria: 1. Patients diagnosed with diabetes meeting the diagnostic criteria of the Chinese Diabetes Prevention and Treatment Guidelines (2024 Edition); 2. Frequency-matched with the case group by age and diabetes duration (ratio approximately 1:1), with gender composition difference <=5 percentage points; 3. No evidence of malignancy in clinical or examination data during current hospitalisation (including imaging studies showing no suspicious malignant lesions); 4. Complete key metabolic and relevant laboratory parameters.

Exclusion criteria

Exclusion criteria: Case group (diabetes with asymptomatic detection of malignancy during hospitalisation) exclusion criteria: 1. History of malignancy or hereditary tumour syndromes; 2. Concurrent severe organ dysfunction (e.g., decompensated cardiac/hepatic/renal failure); 3. Systemic hormonal or immunosuppressive therapy lasting >=3 months within the past 5 years, or immunosuppressed status (solid organ transplant recipients, HIV infection, etc.); 4. Concurrent acute metabolic disorder (DKA, HHS) or acute infection during current hospitalisation; Control group (diabetes without in-hospital detection of malignancy) exclusion criteria: 1. Any history of malignancy; 2. Imaging evidence of uncharacterised or suspicious malignant lesions (e.g., TI-RADS >=4 or BI-RADS >=4); 3. Concurrent acute metabolic disorder (DKA, HHS) or acute infection during current hospitalisation; 4. Continuous systemic hormone or immunosuppressive therapy for >=3 months within the past 5 years, or immunosuppressed status (solid organ transplant recipients, HIV infection, etc.).

Design outcomes

Primary

MeasureTime frame
Incident detection of asymptomatic malignancy during the index hospitalization.;

Secondary

MeasureTime frame
Early in-hospital glycaemic control and glycaemic variability indices;Beta-cell function: two-hour post-load C-peptide;Lipid and nutritional markers: apolipoprotein A-I and serum albumin;Serum tumor marker panel;

Countries

China

Contacts

Public ContactShichun Du

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

dushichun211@163.com+86 21 2507 7538

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026