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Comparative study of clinicopathological features in pancreatic cancer patients with or without type 2 diabetes mellitus

Comparative study of clinicopathological features in pancreatic cancer patients with or without type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123853
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Pancreatic cancer with diabetes mellitus

Interventions

With type 2 diabetes mellitus group:None
Without type 2 diabetes mellitus group:None

Sponsors

Weihai Municipal Hospital Affiliated to Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Disease diagnosis:Histopathologically confirmed pancreatic ductal adenocarcinoma (PDAC) after surgery, classified as stage I or II according to the AJCC 8th edition, with complete clinicopathological data. 2. Specimen availability:Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue and adjacent non-tumor tissue (distance from tumor margin >2 cm), with sufficient quantity and quality to complete all planned pathological assays. 3. Group-specific criteria:PC-DM group (experimental group):A definite diagnosis of diabetes mellitus (DM) recorded within 3 years prior to the diagnosis of PDAC, meeting the WHO diagnostic criteria for diabetes (typical diabetic symptoms plus random plasma glucose >=11.1 mmol/L, or fasting plasma glucose >=7.0 mmol/L, or 2-hour plasma glucose during OGTT >=11.1 mmol/L, or HbA1c >=6.5%). PC-NDM group (control group):No history of diabetes mellitus, with preoperative fasting plasma glucose <6.1 mmol/L and HbA1c <5.7%. 4. Data completeness:Availability of essential clinical data required for this study, including but not limited to age, sex, BMI, tumor stage, preoperative serum CA19-9 level, and history of diabetes-related treatment.

Exclusion criteria

Exclusion criteria: 1. Other types of diabetes mellitus, such as type 1 diabetes mellitus or gestational diabetes mellitus. 2. Receipt of neoadjuvant chemotherapy or radiotherapy before surgery, which may affect tissue morphology. 3. Concomitant other pancreatic diseases, such as chronic pancreatitis or intraductal papillary mucinous neoplasm (IPMN). 4. Interference by systemic diseases, such as concomitant other known malignant tumors, or severe hepatic or renal insufficiency. 5. Poor quality of data or specimens, e.g., severely missing or incomplete clinical data that preclude accurate grouping or analysis, or pathological tissue specimens deemed of insufficient quality or quantity to meet experimental requirements. 6. Pathological diagnosis of other pancreatic malignancies, such as adenosquamous carcinoma, colloid carcinoma, or neuroendocrine tumor. 7. Advanced cancer stage, i.e., patients with pathological stage III or IV.

Design outcomes

Primary

MeasureTime frame
Baseline clinical characteristics;Clinical laboratory indicators;Degree of immune cell infiltration;

Secondary

MeasureTime frame
Serum CA19-9 level;Islet cell apoptosis index;IAPP deposition score;

Countries

China

Contacts

Public ContactHaiyan Chi

Weihai Municipal Hospital Affiliated to Shandong University

zhaoweichihaiyan@163.com+86 156 6231 6550

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026