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

NCT04189393 | Unknown

• 1 other identifier: 2019-5859
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Gastrointestinal Cancer; Colorectal Cancer; Pancreatic Cancer; Esophageal Cancer; Rectum Neoplasm; Esophageal Neoplasms; Pancreatic Ductal Adenocarcinoma; Colonic Neoplasms; Gastrointestinal Microbiome; Microbiota; Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• 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

  Changes of the microbiome composition during the surgical treatment quantified as alpha-diversity by 16S rRNA sequencing. Samples will be collected on 7 moments, starting one month before surgery until three months after surgery.

  4 months

Secondary Outcomes (5)

• Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with neo-adjuvant therapy

  1 month

• Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with antibiotic prophylaxis

  1 week

• Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with bowel preparation

  1 week

• Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with selective decontamination of the digestive tract (SDD)

  1 week

• Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated to the development of infectious complications (30-day)

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients who are presented/present at the participating hospitals with a proven gastrointestinal malignancy and scheduled for surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

Four types of samples will be collected for microbiome analysis: saliva, feces, intraoperative mucosal swabs and drain fluid.

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Esophageal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Head and Neck Neoplasms; Esophageal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan AW Bouwense, MD PhD

  Radboud University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

• Martijn WJ Stommel, MD PhD

  Radboud University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

• Harry van Goor, MD PhD

  Radboud University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa NN Arron, MD

CONTACT

+31243613983; melissa.arron@radboudumc.nl

Richard PG ten Broek, MD PhD

CONTACT

+31243668086; richard.tenbroek@radboudumc.nl

Study Design

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

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 6, 2019
• Study Start: January 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 6, 2019

Record last verified: 2019-11