Colorectal Cancer RecurrentNCT07057076
Microbiome and Colorectal Cancer Recurrence
An observational study of Colorectal Cancer Recurrent, run by Hospital del Mar.
Trial summary
Anastomotic leak is associated with higher rates of tumor recurrence after colorectal cancer surgery. However, the mechanisms responsible remain unknown. The aim of this study is to identify associations between the peritoneal microbiome and recurrence in colorectal cancer patients with postoperative anastomotic leak. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Recurrent
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 1 Jun 2024
- How long will I take part?
- 5 Years
- 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: Colorectal cancer patients operated on for cure and complicated with anastomotic leak.
Who may be able to join
- Colorectal cancer patients operated on for cure and complicated with anastomotic leak.
Who cannot join
- Non-curative resection.
- Urgent surgery.
About this study
Official title: The Role of Microbiome in Recurrence After Colorectal Cancer Surgery With Postoperative Organ/Space Surgical Site Infection
Anastomotic leak is associated with higher rates of tumor recurrence after colorectal cancer surgery. However, the mechanisms responsible remain unknown. The aim of this study is to identify associations between the peritoneal microbiome and recurrence in colorectal cancer patients with postoperative anastomotic leak. This is a single-center retrospective study of patients undergoing colorectal cancer surgery complicated with anastomotic leak between 2004 and 2012. Samples of peritoneal fluid were collected either through percutaneous drainage or reoperation, and microbiome was analyzed using whole genome shotgun. Oncological outcomes are registered. Associations between peritoneal microbiome and tumor recurrence are investigated.
- Conditions
- Colorectal Cancer Recurrent
- Keywords
- Colorectal cancer, Anastomotic leak, Microbiome, Tumor recurrence
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak, Recurrence
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 |
|---|---|---|
| Colorectal cancer patients | Colorectal cancer patients operated on for cure and complicated by anastomotic leak |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Colorectal cancer recurrence after surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jan 2004
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer RecurrentStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 51 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca Montcusí Ventura, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057076
- Sponsor's protocol ID
- 2020/9513/I
- Other IDs
- PI19/00643, SGR 00024
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Microbiome in Recurrence After Colorectal Cancer Surgery With Postoperative Organ/Space Surgical Site Infection
- ClinicalTrials.gov ID
- NCT07057076
- Acronym / sponsor ID
- 2020/9513/I
- Conditions
- Colorectal Cancer Recurrent
- Keywords
- Colorectal cancer, Anastomotic leak, Microbiome, Tumor recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Jul 2025 (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.
Anastomotic leak is associated with higher rates of tumor recurrence after colorectal cancer surgery. However, the mechanisms responsible remain unknown. The aim of this study is to identify associations between the peritoneal microbiome and recurrence in colorectal cancer patients with postoperative anastomotic leak. This is a single-center retrospective study of patients undergoing colorectal cancer surgery complicated with anastomotic leak between 2004 and 2012. Samples of peritoneal fluid were collected either through percutaneous drainage or reoperation, and microbiome was analyzed using whole genome shotgun. Oncological outcomes are registered. Associations between peritoneal microbiome and tumor recurrence are investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | –Colorectal cancer patients operated on for cure and complicated by anastomotic leak |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients operated on for cure and complicated with anastomotic leak.
Key inclusion criteria (1 listed)
- Colorectal cancer patients operated on for cure and complicated with anastomotic leak.
Key exclusion criteria (2 listed)
- Non-curative resection.
- Urgent surgery.
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
Recurrence
Time frame: 5 years
Colorectal cancer recurrence after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Recurrent, run by Hospital del Mar.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 5 years). 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 9 Jul 2025.