Pancreas Cancer Clinical Trial
— MiPacOfficial title:
Establishing the Role of the Human Microbiome in Patients With a Presumed Pancreatic or Periampullary (Pre)Malignancy and Pancreatic Resection.
NCT number | NCT06381882 |
Other study ID # | MiPac |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | November 1, 2026 |
The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles. To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | November 1, 2026 |
Est. primary completion date | May 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patient with a resectable, borderline resectable or locally advanced pancreatic and periampullary presumed (pre)malignancy. - The intention of the treatment must be curative including surgery and (neo-)adjuvant chemotherapy. - Willing and able to adhere to the study procedures described in this protocol and to grant the study team access to the electronic patient file and other data that are required to answer the research questions described in this protocol. Exclusion Criteria: - Inability to provide adequate informed consent (e.g. language barrier, illiteracy) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk stratification postoperative complications | The primary objective of this study is to classify patients that undergo pancreatic resection into high and low risk groups for postoperative complications, based on saliva, blood, tumor, bile and/or rectal/faecal microbiome profiles. | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Long time oncological outcomes - site of recurrence | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and long term oncological outcomes (e.g. site of recurrence). | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Long time oncological outcomes - disease free survival | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and long term oncological outcomes (e.g. disease free survival). | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Long time oncological outcomes - overall survival | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and long term oncological outcomes (e.g. overall survival). | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Complications neoadjuvant chemotherapy | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and complications of neoadjuvant chemotherapy. | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Complications adjuvant chemotherapy | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and complications of adjuvant chemotherapy. | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Response to neoadjuvant chemotherapy | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and response to neoadjuvant chemotherapy as judged by computed tomography (CT) scan and histological respons. | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Complications bile duct drainage | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and complications associated with bile duct drainage. | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Postoperative endocrine insufficiency | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and postoperative endocrine insufficiency (defined as need for new pharmacologic intervention). | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge | |
Secondary | Postoperative exocrine insufficiency | Secondary objectives include, but are not limited to, finding associations between microbiome profiles and postoperative exocrine insufficiency (defined as need for new pharmacologic intervention). | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge |
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