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Pancreatic Tumor, BenignMIND-PANCNCT07529626

Association Between Chronic Psychological Stress and Disease Course Outcomes in Pancreatic Cancer

An observational study of Pancreatic Tumor, Benign and Pancreatic Cancer, Adult, run by Shanghai Zhongshan Hospital at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
320 participants
Where
3 sitesChina
Study dates
11 May 2026to 31 Dec 2028
How long will I take part?
3 Years
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Age ≥ 18 years.
  • Histologically or cytologically confirmed diagnosis of pancreatic cancer, or other pancreatic diseases.
  • Conscious, with basic reading/writing or communication skills, able to understand and complete the questionnaire assessments (either independently, with assistance from research staff, or with help from a family member).
  • Voluntarily agree to participate in this study and sign a written informed consent form.

Who cannot join

  • Presence of severe cognitive impairment (e.g., dementia, disturbance of consciousness) or a definite history of psychiatric disorders, judged by the investigator as unable to comply with the study assessments, and without a family member who can help complete the questionnaire assessments.
  • Presence of other severe, uncontrolled systemic diseases (e.g., severe heart, lung, or kidney failure), with an estimated life expectancy < 3 months as judged by the investigator.
  • Inability to understand Chinese or presence of severe visual/hearing impairment that affects completion of the questionnaire assessments, and without a family member who can help complete the questionnaire assessments.

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, 3 recruiting
  • the Third Xiangya Hospital of Central South University

    Changsha, Hunan

    Not yet recruiting
  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

    Liang Liu, 18017317395, liu.liang@zs-hospital.sh.cn

    Recruiting
  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an, Shanxi

    Not yet recruiting

Other trials in China

About this study

Official title: A Prospective Cohort Study on the Association Between Chronic Psychological Stress and Disease Course Outcomes in Pancreatic Cancer: A Comprehensive Analysis Based on Multidimensional Dynamic Psychological Assessment (MIND-PANC)

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.

Read the detailed description

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.

Keywords
pancreatic cancer, anxiety, depression, psychological distress, Hospital Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, disease progression, Overall survival, quality of life
Medical subject headings
Pancreatic Neoplasms, Pancreatic cancer, adult, Anxiety Disorders, Depression, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07529626
Study groupRoleWhat they receive
High Stress CohortPancreatic cancer patients who receive radical resection and exhibit high psychological stress (e.g., defined by a specific cut-off score on the evaluation scale).
Low Stress CohortPancreatic cancer patients who receive radical resection and exhibit low or normal psychological stress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Overall survival (OS) is defined as the duration from the beginning of therapy until death due to any cause.

    Measured: 3 years

Secondary outcomes (4)
  1. progression-free-survival

    Time from the beginning of therapy to the first progression (PD) in patients with pancreatic cancer

    Measured: 3 years

  2. disease-free-survival

    The duration between the date after surgery to the date of any recurrence or death firstly

    Measured: 3 years

  3. The prevalence of depression and/or anxiety among participants as assesed by HADS and PSQI questionnaire

    Measured: 3 weeks

  4. recurrence rate of different types and sites

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start11 May 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
320 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07529626
Sponsor's protocol ID
B2026-092R
Acronym
MIND-PANC
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Peng F, Lu J, Su K, Liu X, Luo H, He B, Wang C, Zhang X, An F, Lv D, Luo Y, Su Q, Jiang T, Deng Z, He B, Xu L, Guo T, Xiang J, Gu C, Wang L, Xu G, Xu Y, Li M, Kelley KW, Cui B, Liu Q. Oncogenic fatty acid oxidation senses circadian disruption in sleep-deficiency-enhanced tumorigenesis. Cell Metab. 2024 Jul 2;36(7):1598-1618.e11. doi: 10.1016/j.cmet.2024.04.018. Epub 2024 May 20.

    PubMed 38772364
  • Pariollaud M, Ibrahim LH, Irizarry E, Mello RM, Chan AB, Altman BJ, Shaw RJ, Bollong MJ, Wiseman RL, Lamia KA. Circadian disruption enhances HSF1 signaling and tumorigenesis in Kras-driven lung cancer. Sci Adv. 2022 Sep 30;8(39):eabo1123. doi: 10.1126/sciadv.abo1123. Epub 2022 Sep 28.

    PubMed 36170373
  • Peng Z, Song J, Zhu W, Bao H, Hu Y, Shi Y, Cheng X, Jiang M, Fang F, Chen J, Shu X. Impact of sleep deprivation on colon cancer: Unraveling the KynA-P4HA2-HIF-1alpha axis in tumor lipid metabolism and metastasis. Mol Metab. 2025 Mar;93:102109. doi: 10.1016/j.molmet.2025.102109. Epub 2025 Feb 6.

    PubMed 39920992
  • Liu JL, Xu X, Rixiati Y, Wang CY, Ni HL, Chen WS, Gong HM, Zhang ZL, Li S, Shen T, Li JM. Dysfunctional circadian clock accelerates cancer metastasis by intestinal microbiota triggering accumulation of myeloid-derived suppressor cells. Cell Metab. 2024 Jun 4;36(6):1320-1334.e9. doi: 10.1016/j.cmet.2024.04.019.

    PubMed 38838643
  • Li Y, Yu H, Li ZM, Yin KW, Jin SY, Chen CC, Tan MS, Zhang CJ, Liu XH, Li WP, Yang JM, Zhou AJ, Zhang X, Ni ED, Wang ML, Mo H, Qin C, Hu J, Li SJ, Gao TM, Li JM. Colorectal cancer cells hijack a brain-gut polysynaptic circuit from the lateral septum to enteric neurons to sustain tumor growth. Nat Cancer. 2025 Nov;6(11):1800-1820. doi: 10.1038/s43018-025-01033-x. Epub 2025 Aug 21.

    PubMed 40841473
  • Zhou R, Li K, Hu X, Fan S, Gao Y, Xue X, Bu Y, Zhang H, Wang Y, Wei C, Zhang S, Xie Z, Liu C, Chen P, Yin Z, Ren D. Sleep Deprivation Activates a Conserved Lactate-H3K18la-RORalpha Axis Driving Neutrophilic Inflammation Across Species. Adv Sci (Weinh). 2025 Oct;12(38):e04028. doi: 10.1002/advs.202504028. Epub 2025 Jul 21.

    PubMed 40686333
  • Cui B, Luo H, He B, Liu X, Lv D, Zhang X, Su K, Zheng S, Lu J, Wang C, Yang Y, Zhao Z, Liu X, Wang X, Zhao Y, Nie X, Jiang Y, Zhang Z, Liu C, Chen X, Cai A, Lv Z, Liu Z, An F, Zhang Y, Yan Q, Kelley KW, Xu G, Xu L, Liu Q, Peng F. Gut dysbiosis conveys psychological stress to activate LRP5/beta-catenin pathway promoting cancer stemness. Signal Transduct Target Ther. 2025 Mar 5;10(1):79. doi: 10.1038/s41392-025-02159-1.

    PubMed 40038255
  • Zeng Y, Hu CH, Li YZ, Zhou JS, Wang SX, Liu MD, Qiu ZH, Deng C, Ma F, Xia CF, Liang F, Peng YR, Liang AX, Shi SH, Yao SJ, Liu JQ, Xiao WJ, Lin XQ, Tian XY, Zhang YZ, Tian ZY, Zou JA, Li YS, Xiao CY, Xu T, Zhang XJ, Wang XP, Liu XL, Wu F. Association between pretreatment emotional distress and immune checkpoint inhibitor response in non-small-cell lung cancer. Nat Med. 2024 Jun;30(6):1680-1688. doi: 10.1038/s41591-024-02929-4. Epub 2024 May 13.

    PubMed 38740994

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Tumor, Benign and Pancreatic Cancer, Adult, run by Shanghai Zhongshan Hospital 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: looking for participants now, as of the sponsor's last update on 29 Jun 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07529626, which also lists 8 linked publications.

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 29 Jun 2026.

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