Clinical trial · Observational

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

NCT04189393CI-TRIAL-00042090MA-PPINGunknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (11)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Anastomotic Leak	—	UNRESOLVED	—
Colonic Neoplasms	Colon Neoplasm	ALIAS	0.90
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Esophageal Neoplasms	Esophageal Neoplasm	ONTOLOGY_EXACT	0.98
Gastrointestinal Cancer	Malignant Digestive System Neoplasm	ALIAS	0.90
Gastrointestinal Microbiome	—	UNRESOLVED	—
Microbiota	—	UNRESOLVED	—
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92
Pancreatic Ductal Adenocarcinoma

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

[]

Primary outcomes (1)

measure
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
description
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.

Secondary outcomes (5)

measure
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with neo-adjuvant therapy
timeFrame
1 month
description
The effect of neo-adjuvant therapy on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
measure
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with antibiotic prophylaxis

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.