NCT07843147

Brief Summary

This prospective, single-center observational study investigates whether continuous glucose monitoring (CGM, 14 days) and gut microbiota composition (from a fecal sample) reveal patterns specific to pancreatic cancer, aiming to contribute to earlier detection and better assessment of disease severity. Adult patients under investigation, follow-up, or treatment for benign or malignant pancreatic/periampullary conditions are invited to participate in either or both parts of the study.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
61mo left

Started Oct 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

continuous glucose monitoringgut microbiotapancreatic cancerbiomarkerfecal microbiome

Outcome Measures

Primary Outcomes (2)

  • Difference in CGM-derived glycemic variability metrics

    14 days CGM recording period

  • Difference in gut microbiota composition

    Single fecal sample

Study Arms (2)

Patients with pancreatic cancer

Patients with cysts or other benign pancreatic disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of consecutive adult patients evaluated or treated for pancreatic or periampullary diseases at the Department of Surgery/Cancer Center, Umeå University Hospital, Sweden.

You may qualify if:

  • Adults (≥18 years of age).
  • Undergoing clinical investigation, follow-up, or treatment for a pancreatic or periampullary condition (malignant or benign/premalignant, including cystic lesions and pancreatitis).
  • Willing and able to provide written informed consent for participation in at least one component of the study (continuous glucose monitoring and/or fecal sample collection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal sample for gut microbiota metagenomic sequencing

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic CystHyperglycemiaPrediabetic State

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCystsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes Mellitus

Study Officials

  • Oskar Franklin, M.D, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oskar Franklin, M.D, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2031

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data may be shared with qualified researchers upon reasonable request where permitted by applicable legislation, ethical approvals, and participant consent. Data access requests will be reviewed by the study investigators and the responsible institution. Data sharing may require additional ethical approval and a data sharing agreement. Requests that cannot be accommodated under Swedish and EU data protection regulations will not be approved.