NCT04005118: Microbiota

Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery

Status unknown Last updated 2 July 2019

What this trial tests

trial in Adenocarcinoma of the Colon in 50 participants. Status unknown.

Timeline

28 May 2019

Primary endpoint
1 April 2020

1 April 2020

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	50
Start date	28 May 2019
Primary completion	1 April 2020
Estimated completion	1 April 2020
Sites	1 location across France

Conditions studied

• Adenocarcinoma of the Colon — all drugs for Adenocarcinoma of the Colon →
• Adenocarcinoma of the Rectum — all drugs for Adenocarcinoma of the Rectum →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Adenocarcinoma of the Colon or Adenocarcinoma of the Rectum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intro: Recent studies on colorectal cancer surgery have been focusing on the role of intestinal microbiome on surgical outcomes. Standard perioperative cares, like mechanic bowel preparation (MBP), administration of antibiotics (ABT) and surgery-related stress and injury influence the microbiome composition and possibly induce a shift toward a microbiome dysbiotic state, which predisposes to complicated postoperative course. Microbiome composition changes and enhanced virulence factors may increase the risk of postoperative complications, such as anastomotic leakage (AL), surgical site infection (SSI), and postoperative ileus (PI), which are known to impact on patient's overall survival and cancer recurrence.

Objective: The primary objective is to investigate if a significant association might exist between the microbiome composition and the occurrence of postoperative complications at 90 days.

Methods: 3 different microbiome samples will be taken from all patients. Two fresh fecal samples for detection of LM and fecal water preparation: a) a day before the surgery before MBP and/or ABT (LM1), b) postoperatively after first bowel movement (LM2). One sample will be taken intra-operatively from the stapled resection lines of circular stapler used for forming a colorectal anastomosis, to detect the MAM and to perform immunohistochemistry staining for detection of HACE1 expression.

DNA analysis will be performed for all samples. IHC will be performed for detecting HACE1 expression in the tumor and colorectal anastomosis tissues using anti-HACE1 antibodies. .

For proliferation assessment, human colon carcinoma cell lines HT29 will be plated in monolayers and scratched with a single scratch. Monolayers will be incubated for 24 hours with fecal water from patients with surgical complications and matched control patients without complications.

Descriptive statistics will be performed to describe the study population. This project aim to describe microbiome composition and its impact on postoperative complications.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of the intestinal microbiome in colorectal cancer surgery outcomes.
   Lauka L, Reitano E, Carra MC, Gaiani F, et al · · 2019 · cited 44× · PMID 31791356 · DOI 10.1186/s12957-019-1754-x
2. Gut microbiota: impacts on gastrointestinal cancer immunotherapy.
   Lau HCH, Sung JJ, Yu J. · · 2021 · cited 42× · PMID 33435800 · DOI 10.1080/19490976.2020.1869504
3. What Is Known about Theragnostic Strategies in Colorectal Cancer.
   Parisi A, Porzio G, Pulcini F, Cannita K, et al · · 2021 · cited 13× · PMID 33535557 · DOI 10.3390/biomedicines9020140
4. Human Colonic Microbiota and Short-Term Postoperative Outcomes in Colorectal Cancer Patients: A Pilot Study.
   Lauka L, Sobhani I, Brunetti F, Mestivier D, et al · · 2021 · cited 2× · PMID 35056490 · DOI 10.3390/microorganisms10010041