Colorectal CancerAPOLLONCT05641129
Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot
An observational study of Colorectal Cancer, run by European Student Research Network at 1 site in United Kingdom.
Trial summary
APOLLO (Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal snapshot) is an international, multi-centre, prospective observational study which will address this need and aims to describe the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2023to 11 Nov 2023
- 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: Consecutive adult patients (≥18 years of age) presenting acutely (i.e. unplanned and non-elective presentation to hospital for urgent or emergency reasons) for symptoms of known or unknown colorectal cancer assessed by hospital surgical teams. Patients should be included regardless of operative or non-operative management, and curative or palliative intent.
Who may be able to join
- Patient pathology: Patients admitted to the hospital acutely with primary colon AND/OR rectal adenocarcinoma and referred to general/colorectal surgical departments:
- Patients who are operated on for curative/palliative treatment of colorectal cancer
- Patients who are referred to general surgery for assessment (irrespective of if they proceed to surgery)
- New diagnoses of colorectal cancer
- Extent of cancer: All patients including extra-abdominal metastatic, intra-abdominal metastatic and non-metastatic disease
- Known cancer: Patients presenting for the first time with colorectal cancer AND/OR known colorectal cancer diagnosis with progression of disease. i.e. obstruction of known colorectal cancer
- Patient presentation: Symptomatic presentation of colorectal cancer i.e. large bowel obstruction, haemorrhage, perforation
Who cannot join
- Presenting for side effects of cancer treatment
- Patients with secondary cancers
- Previously included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot-An International, Multi-centre Study of Emergency Presentations of Colorectal Cancer
APOLLO (Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal snapshot) is an international, multi-centre, prospective observational study which will address this need and aims to describe the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort.
Read the detailed description
Primary aim: Describe the variation in the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort.
Secondary aims:
- Identify risk factors for mortality (intraoperatively, at 30-days and at 90-days) and ostomy rates (at 30- and 90-days) in patients deemed for active management (i.e., not for palliative management) to develop a risk prediction model
- Validate risk criteria of large bowel obstruction in patients with previously known colorectal cancer undergoing neoadjuvant chemotherapy or awaiting elective surgery
Who?
- Patients aged 18 years and above presenting to the hospital acutely with colorectal cancer (CRC) for malignant large bowel obstruction (LBO), perforation, CRC-related haemorrhage or other reasons within the data collection periods. Both those managed with and without surgery will be included
- Patients with localised and metastatic disease will be included
- Patients with known colorectal cancer diagnoses will be included if they present acutely (e.g., with disease progression)
- Patients presenting acutely for the side effects of chemotherapy/radiotherapy of known cancers will be excluded
What? Data will be collected on patients' presenting status and symptoms, patient management strategies, and intraoperative and postoperative outcomes.
When? Prospectively over 2023 in consecutive 6-week data collection blocks between January and June with 90-day follow-up till September.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal surgery, colorectal cancer, colonic stenting, emergency surgery
- Medical subject headings
- Colorectal Neoplasms
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 |
|---|---|---|
| Main Cohort | Consecutive adult patients (≥18 years of age) presenting acutely (i.e. unplanned and non-elective presentation to hospital for urgent or emergency reasons) for symptoms of known or unknown colorectal cancer assessed by hospital surgical teams. Patients should be included regardless of operative or non-operative management, and curative or palliative intent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Mortality since day of presentation
Measured: 90-day
Secondary outcomes (9)
Secondary outcome 1
Inpatient mortality, mortality since day of presentation
Measured: 30-day
Secondary outcome 2
Operative mortality rates
Measured: 30- and 90-day
Secondary outcome 3
Rates of primary anastomosis
Measured: 30- and 90-day
Secondary outcome 4
Stoma formation and reversal rates
Measured: 30- and 90-day
Secondary outcome 5
Rate and grade of surgical complications
Measured: 90-day
Secondary outcome 6
Rates of stenting in those with left-sided LBO, rates of stenting in those treated with palliative intent, rate of colonic stenting complications
Measured: 30- and 90-day
Secondary outcome 7
Rate of representation for patients managed nonoperatively
Measured: 30- and 90-day
Secondary outcome8
Rates of radiological assessment on admission
Measured: 30- and 90-day
Secondary outcome 9
Proportion of patients presenting acutely with large bowel obstruction with known colorectal cancer who had high risk criteria for obstruction (as defined by the FOXTroT obstruction criteria) at index assessment
Measured: 30- and 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start16 Jan 2023
- Primary completion11 Sep 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Student Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641129
- Sponsor's protocol ID
- APOLLO Study
- Acronym
- APOLLO
- Status last verified
- Feb 2023
- First submitted
- 17 Nov 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Centre-summaries will be made available to respective centres for audit purposes.
Publications
EuroSurg Collaborative and STARSurg Collaborative. Global Use and Outcomes of Endoscopic Stenting in Acute Malignant Left-Sided Colonic Obstruction: A Secondary Analysis of APOLLO, An International, Prospective Cohort Study. Dis Colon Rectum. 2025 Dec 1;68(12):1458-1467. doi: 10.1097/DCR.0000000000003960. Epub 2025 Oct 10.
PubMed 41070782
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot-An International, Multi-centre Study of Emergency Presentations of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05641129
- Acronym / sponsor ID
- APOLLO / APOLLO Study
- Conditions
- Colorectal Cancer
- Keywords
- colorectal surgery, colorectal cancer, colonic stenting, emergency surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- European Student Research NetworkResearch network
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 7 Dec 2022 (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.
APOLLO (Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal snapshot) is an international, multi-centre, prospective observational study which will address this need and aims to describe the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort.
Detailed description
Primary aim: Describe the variation in the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort.
Secondary aims:
- Identify risk factors for mortality (intraoperatively, at 30-days and at 90-days) and ostomy rates (at 30- and 90-days) in patients deemed for active management (i.e., not for palliative management) to develop a risk prediction model
- Validate risk criteria of large bowel obstruction in patients with previously known colorectal cancer undergoing neoadjuvant chemotherapy or awaiting elective surgery
Who?
- Patients aged 18 years and above presenting to the hospital acutely with colorectal cancer (CRC) for malignant large bowel obstruction (LBO), perforation, CRC-related haemorrhage or other reasons within the data collection periods. Both those managed with and without surgery will be included
- Patients with localised and metastatic disease will be included
- Patients with known colorectal cancer diagnoses will be included if they present acutely (e.g., with disease progression)
- Patients presenting acutely for the side effects of chemotherapy/radiotherapy of known cancers will be excluded
What? Data will be collected on patients' presenting status and symptoms, patient management strategies, and intraoperative and postoperative outcomes.
When? Prospectively over 2023 in consecutive 6-week data collection blocks between January and June with 90-day follow-up till September.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | –Consecutive adult patients (≥18 years of age) presenting acutely (i.e. unplanned and non-elective presentation to hospital for urgent or emergency reasons) for symptoms of known or unknown colorectal cancer assessed by hospital surgical teams. Patients should be included regardless of operative or non-operative management, and curative or palliative intent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients (≥18 years of age) presenting acutely (i.e. unplanned and non-elective presentation to hospital for urgent or emergency reasons) for symptoms of known or unknown colorectal cancer assessed by hospital surgical teams. Patients should be included regardless of operative or non-operative management, and curative or palliative intent.
Key inclusion criteria (7 listed)
- Patient pathology: Patients admitted to the hospital acutely with primary colon AND/OR rectal adenocarcinoma and referred to general/colorectal surgical departments:
- Patients who are operated on for curative/palliative treatment of colorectal cancer
- Patients who are referred to general surgery for assessment (irrespective of if they proceed to surgery)
- New diagnoses of colorectal cancer
- Extent of cancer: All patients including extra-abdominal metastatic, intra-abdominal metastatic and non-metastatic disease
Key exclusion criteria (3 listed)
- Presenting for side effects of cancer treatment
- Patients with secondary cancers
- Previously included in the study
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
Primary outcome
Time frame: 90-day
Mortality since day of presentation
9 secondary outcomes
Secondary outcome 1
Time frame: 30-day
Secondary outcome 2
Time frame: 30- and 90-day
Secondary outcome 3
Time frame: 30- and 90-day
Secondary outcome 4
Time frame: 30- and 90-day
Secondary outcome 5
Time frame: 90-day
Secondary outcome 6
Time frame: 30- and 90-day
Secondary outcome 7
Time frame: 30- and 90-day
Secondary outcome8
Time frame: 30- and 90-day
Secondary outcome 9
Time frame: 30- and 90-day
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 20 Feb 2024.
- Derived from this study: PubMed 41070782EuroSurg Collaborative and STARSurg Collaborative. Global Use and Outcomes of Endoscopic Stenting in Acute Malignant Left-Sided Colonic Obstruction: A Secondary Analysis of APOLLO, An International, Prospective Cohort Study. Dis Colon Rectum. 2025 Dec 1;68(12):1458-1467. doi: 10.1097/DCR.0000000000003960. Epub 2025 Oct 10.
- Individual participant dataSharing planned: No. Centre-summaries will be made available to respective centres for audit purposes.
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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.
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 Colorectal Cancer, run by European Student Research Network at 1 site in United Kingdom.
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 7 inclusion and 3 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 20 Feb 2024. 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 United Kingdom. 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?
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?
Primary outcome (time frame: 90-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641129, which also lists 1 linked publication.
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 20 Feb 2024.