An observational study in Pancreatic Tumor, Benign, Pancreatic Cancer, Adult and Pancreatic Cancer Resectable, sponsored by Shanghai Zhongshan Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Shanghai Zhongshan Hospital · Observational
This is a prospective, observational cohort study (MIND-PANC) to explore the associations of chronic psychological stress with disease progression, treatment outcomes, and prognosis of pancreatic cancer.
Researchers will ask participants to fill out simple questionnaires about their mood, worries, and sleep at the start of the study and at regular follow-up visits. The study will also collect a small blood sample (leftover from routine care) to measure stress-related markers.
Investigators hypothesize that pancreatic cancer patients who have higher levels of ongoing psychological stress (such as anxiety, depression, or poor sleep) tend to have shorter survival times, a higher chance of recurrence, and a poorer response to treatment, compared to patients with lower stress levels.
Study Design and Population This is a multicenter, prospective, observational cohort study designed to investigate whether chronic psychological stress (anxiety, depression, and sleep disturbance) is independently associated with disease course outcomes in patients with pancreatic cancer.
Study Procedures At baseline (day 0), participants complete validated self-report instruments: the Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Pittsburgh Sleep Quality Index (PSQI). Clinical data are extracted from medical records (demographics, tumor stage, CA19-9, treatment history, comorbidities, etc.). A 2 mL remnant peripheral blood sample (collected during routine morning phlebotomy) is obtained for serum separation and storage at -80 °C; samples will be shipped to the central laboratory (Zhongshan Hospital) for batch analysis of biomarkers.
Follow-up assessments occur at key clinical time points (neoadjuvant therapy mid-point, adjuvant therapy mid-point, end of adjuvant therapy, 12-month long-term follow-up, and at disease progression/recurrence). Psychological scales are repeated at each time point. Clinical outcomes (recurrence, progression, treatment modifications, adverse events, survival status) are captured every 3 months via medical records or telephone contact.
Quality Assurance and Data Management
Quality assurance plan: All sites receive standardized training on study procedures, scale administration, and GCP principles. Regular multicenter meetings and annual on-site monitoring/remote auditing by the coordinating center (Fudan University Zhongshan Hospital) are conducted.
Data validation: A web-based electronic data capture (EDC) system is used with automated range and logic checks. Queries are generated for out-of-range or inconsistent entries.
Source data verification (SDV): A random sample of 10% of participants will undergo SDV against original medical records. For key endpoints (OS, PFS, and psychological scores), 100% SDV will be performed.
Data dictionary: A comprehensive data dictionary defines all variables, including coding dictionaries (MedDRA for adverse events, WHO Drug Dictionary for concomitant medications).
Standard Operating Procedures (SOPs): SOPs govern recruitment, informed consent, psychological assessment, biospecimen handling, data entry, adverse event reporting, and protocol amendments.
Sample Size Assessment The sample size of 320 patients was calculated based on the primary outcome (OS) using a two-sided alpha of 0.05, power of 80%, a hazard ratio (HR) of 1.5 (high vs. low psychological stress), an event rate of 67.5%, and 10% loss to follow-up. The Schoenfeld formula yields at least 192 death events and 285 completed patients; after accounting for dropouts, 317 patients are needed, rounded to 320. The HR of 1.5 is justified by recent literature and represents a clinically meaningful medium effect size while maintaining feasibility.
Handling of Missing Data For OS, missing survival dates are minimized by active follow-up. For covariates and scale items with random missingness (\<15%), multiple imputation (MI) will be used, with complete-case analysis as sensitivity.
Statistical Analysis Plan
Primary analysis: Kaplan-Meier curves, log-rank tests, and multivariable Cox proportional hazards models (adjusting for study center, age, TNM stage, surgery, ECOG score, etc.) will be used to estimate the HR for OS. The proportional hazards assumption will be tested by Schoenfeld residuals.
Secondary analyses: Similar Cox models will be applied to PFS. Longitudinal trajectories of psychological scores (HADS, PHQ-9, GAD-7, PSQI) will be modeled using generalized estimating equations (GEE).
Subgroup and sensitivity analyses: Pre-specified subgroups (by TNM stage, surgery type, age, site) will be examined with interaction tests. Sensitivity analyses will use alternative definitions of psychological stress (e.g., continuous z-score) and different missing data methods.
Bias assessment: E-values will be calculated for unmeasured confounding. Selection bias will be assessed by comparing completers vs. dropouts; worst-case scenario sensitivity analyses will be performed.
Ethics and Dissemination The protocol (version V1.4, dated 20260302) has been approved by the ethics committees of all participating centers. Results will be published in peer-reviewed journals regardless of outcome direction.
25 studies on the registry are indexed under Pancreatic cancer, adult; 18 are open to participants now.
Browse Pancreatic cancer, adult studies →Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
Compared within Pancreatic cancer, adult, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pancreatic Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with newly diagnosed or existing pancreatic cancer or other pancreatic diseases who receive care at the Department of Pancreatic Surgery, Zhongshan Hospital Fudan University (Shanghai); the First Affiliated Hospital of Xi'an Jiaotong University (Xi'an); and the Third Xiangya Hospital of Central South University (Changsha). Participants are recruited consecutively from inpatient clinics of these three tertiary hospitals in China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pancreatic cancer patients who receive radical resection and exhibit high psychological stress (e.g., defined by a specific cut-off score on the evaluation scale).
Pancreatic cancer patients who receive radical resection and exhibit low or normal psychological stress
overall survival
Overall survival (OS) is defined as the duration from the beginning of therapy until death due to any cause.
Time frame: 3 years
progression-free-survival
Time from the beginning of therapy to the first progression (PD) in patients with pancreatic cancer
Time frame: 3 years
disease-free-survival
The duration between the date after surgery to the date of any recurrence or death firstly
Time frame: 3 years
The prevalence of depression and/or anxiety among participants as assesed by HADS and PSQI questionnaire
Time frame: 3 weeks
recurrence rate of different types and sites
Time frame: 3 years
The correlation between peripheral stress and inflammatory biomarker and chronic psychological stress scores and the survival outcomes
Peripheral stress and inflammatory biomarker： \- The baseline concentration of peripheral venous blood is collected. The peripheral stress and inflammatory biomarkers include cortisol, ACTH,IL-6,TNF-α and CRP. Chronic psychological stress： - The baseline psychological stress score is assessed using HADS(Anxiety and Depression) and PSQI(Sleep quality) questionnaires. Survival outcomes include: \- Overall survival, Disease free survival, Progression free survival, Negative margin resection rate.
Time frame: 3 years
Plan to share: Undecided
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