Adenocarcinoma of the ColonMicrobiotaNCT04005118
Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery
An observational study of Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2019to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with rectal or left colon adenocarcinoma
Who may be able to join
- Adult ≥ 18 years old
- With histologically confirmed rectal or left colon adenocarcinoma by biopsy material from colonoscopy
- Having elective colorectal surgery after standardized bowel preparation
- Affiliated to a social security system
- Signature of informed consent
Who cannot join
- Major surgery 30 days before scheduled colorectal surgery
- Administration of systemic antibiotic therapy within 30 days prior to planned colorectal surgery
- Presenting a contraindication to elective colorectal surgery
- Patient protected by law
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Dr Lelde Lauka
Créteil, 94000
Lauka Lelde, PhD
About this study
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.
Read more
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.
- Keywords
- Intestinal microbiome, colorectal cancer, mechanical bowel preparation, postoperative complications, anastomotic leakage
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms, Postoperative Complications, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preoperative preparation on microbiome composition | Mechanical Bowel Preparation + oral antibiotics group: receiving mechanical bowel preparation only MBP will be prepared with 4 liters of Polyethylene glycol (PEG) solution to be started 24 hours before the planned surgery. 500mg of Metronidazole will be administrated 3 times one day before the surgery at 2 pm, 3 pm and 10 pm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anastomotic leakage
detected by imaging techiques (CT scan or MRI)
Measured: 90 days after surgery
Rate of surgical site infection
1)superficial and deep infection:clinical observation of purulent discharge from the wound and/or bacterial staining from the wound 2)organ or deep space infection: imaging techniques (CT, MRI, USS)
Measured: 90 days after surgery
Rate of prolonged postoperative ileuss
detected by clinical observation of the first bowel movement after the surgery
Measured: 90 days after surgery
Secondary outcomes (7)
microbiome composition
The composition of luminal microbiome and mucosal-associated microbiome will be studied by DNA analyses from fresh fecal samples and surgical anastomosis material, accordingly
Measured: 3 months after study start date
microbiome composition
The composition of luminal microbiome and mucosal-associated microbiome will be studied by DNA analyses from fresh fecal samples and surgical anastomosis material, accordingly
Measured: 6 months after study start date
impact of microbiome composition on length of hospitalization
length of hospitalization will be detected and analyzed in association with microbiome composition
Measured: at the time of patient's discharge of the hospital
Correlation between detected bacterial OTUs (Operation Taxonomic Units) and the event of reintervention
In the patient group with the event of reintervention, an abundance of specific OTUs will be analysed in compare with patients with no event of reintervention.
Measured: 90 days after surgery
impact of microbiome metabolites on intestinal epithelial cell proliferation and wound healing
Monolayers of human colon cancer cell lines HT29 will be incubated for 24 hours with fecal water from patients with surgical complications and matched control patients without complications.
Proliferation will be calculated in two manners: 1) The time of the closure of the scratch defect will be evaluated and compared in the two group., 2)Proliferation rate will be analyzed by immunohistochemistry marker Ki 67, expression of Ki 67 will be evaluated in cells at the borders of the scratch defect
Measured: 6 months after study start date
Expression intensity in cytoplasm of protein ligase HACE1 in tumoral and non-tumoral tissues
Immunohistochemistry with anti-HACE1 antibodies will be used to detect expression levels in tumoral (colorectal cancer) and non-tumoral (anastomotic sample) tissues. In a case of decreased expression, tissues will be analyzed by methylation PCR to detect an aberrant methylation of HACE1 and its hypermethylation
Measured: 6 months after study start date
Expression intensity in cytoplasm of protein ligase HACE1 in tumoral and non-tumoral tissues
Immunohistochemistry with anti-HACE1 antibodies will be used to detect expression levels in tumoral (colorectal cancer) and non-tumoral (anastomotic sample) tissues. In a case of decreased expression, tissues will be analyzed by methylation PCR to detect an aberrant methylation of HACE1 and its hypermethylation
Measured: 3 months after study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start28 May 2019
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ColonStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lelde Lauka, PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005118
- Sponsor's protocol ID
- APHP190088
- Acronym
- Microbiota
- Status last verified
- May 2019
- First submitted
- 15 Mar 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT04005118
- Acronym / sponsor ID
- Microbiota / APHP190088
- Keywords
- Intestinal microbiome, colorectal cancer, mechanical bowel preparation, postoperative complications, anastomotic leakage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative preparation on microbiome composition | – | –Mechanical Bowel Preparation + oral antibiotics group: receiving mechanical bowel preparation only MBP will be prepared with 4 liters of Polyethylene glycol (PEG) solution to be started 24 hours before the planned surgery. 500mg of Metronidazole will be administrated 3 times one day before the surgery at 2 pm, 3 pm and 10 pm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with rectal or left colon adenocarcinoma
Key inclusion criteria (5 listed)
- Adult ≥ 18 years old
- With histologically confirmed rectal or left colon adenocarcinoma by biopsy material from colonoscopy
- Having elective colorectal surgery after standardized bowel preparation
- Affiliated to a social security system
- Signature of informed consent
Key exclusion criteria (5 listed)
- Major surgery 30 days before scheduled colorectal surgery
- Administration of systemic antibiotic therapy within 30 days prior to planned colorectal surgery
- Presenting a contraindication to elective colorectal surgery
- Patient protected by law
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of anastomotic leakage
Time frame: 90 days after surgery
detected by imaging techiques (CT scan or MRI)
Rate of surgical site infection
Time frame: 90 days after surgery
1)superficial and deep infection:clinical observation of purulent discharge from the wound and/or bacterial staining from the wound 2)organ or deep space infection: imaging techniques (CT, MRI, USS)
Rate of prolonged postoperative ileuss
Time frame: 90 days after surgery
detected by clinical observation of the first bowel movement after the surgery
7 secondary outcomes
microbiome composition
Time frame: 3 months after study start date
microbiome composition
Time frame: 6 months after study start date
impact of microbiome composition on length of hospitalization
Time frame: at the time of patient's discharge of the hospital
Correlation between detected bacterial OTUs (Operation Taxonomic Units) and the event of reintervention
Time frame: 90 days after surgery
impact of microbiome metabolites on intestinal epithelial cell proliferation and wound healing
Time frame: 6 months after study start date
Expression intensity in cytoplasm of protein ligase HACE1 in tumoral and non-tumoral tissues
Time frame: 6 months after study start date
Expression intensity in cytoplasm of protein ligase HACE1 in tumoral and non-tumoral tissues
Time frame: 3 months after study start date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lelde Lauka, PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lelde Lauka, PHD (01 49 81 41 74 ext. +33, lelde.lauka@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anastomotic leakage (time frame: 90 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.