UnknownNot Applicable

Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery

60 participantsStarted 2020-01-01

Plain-language summary

The MA-PPING is a multicenter prospective observational study that includes patients undergoing surgery for gastrointestinal cancer. The study aims to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer during their surgical patient journey from the moment of diagnosis until full recovery (three months after surgery).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with proven malignancy of the distal esophagus, pancreatic head/corpus, colon or rectum * Patients undergoing primary elective surgery with construction of an anastomosis of the gastrointestinal tract * Adult patients above age 18 years * Written informed consent Exclusion Criteria: * History of chronic gastro-intestinal disease e.g. Crohns disease and ulcerative colitis * Presence of acute gastrointestinal infection * Chronic use of oral antibiotics (3 months or longer) * Patients undergoing gastrointestinal surgery for gastrointestinal cancer in acute setting * Patients undergoing construction of an end/loop colostomy or ileostomy (following primary resection) * Patients undergoing colon and/ or rectal resection without construction of an anastomosis * Patients who have insufficient knowledge of the Dutch language * Patients who are not able to give reliable answers to the questionnaires due to a (mental) disease or (cognitive) condition * Patients who are not able to collect microbiome samples due to a physical or mental condition

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compositional changes of the oral and gut microbiome, assessed by alpha-diversity using 16S rRNA (ribosomal ribonucleic acid) sequencing, described in a surgical patient journey from moment of diagnosis until full recovery

Timeframe: 4 months

Trial details

NCT IDNCT04189393

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-11-01

Contact for this trial

Melissa NN Arron, MD

+31243613983 melissa.arron@radboudumc.nl

View on ClinicalTrials.gov More Gastrointestinal Cancer trials