Rectal CancerNCT05696002
Advanced Pelvic Surgical Oncology Database - Prospective Observational Study
An observational study of Rectal Cancer and Pelvic Cancer, run by Glasgow Royal Infirmary at 1 site in United Kingdom.
Trial summary
Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, Pelvic Cancer, Gynecologic Cancer
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2023to 1 Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tertiary referral centre
Who may be able to join
- Advanced pelvic oncological resection defined as more than 1 pelvic organ resected
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Academic Department of Surgery, Glasgow Royal Infirmary
Glasgow
Norman Galbraith, MSc PhD MRCS, 07449784948
Norman Galbraith, PhD MRCS
About this study
Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.
Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.
Read the detailed description
Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.
Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study..
- Conditions
- Rectal Cancer, Pelvic Cancer, Gynecologic Cancer, Colon Cancer
- Keywords
- Pelvic exenteration, Abdominoperineal resection, Reconstructive flap, Rectal cancer
- Medical subject headings
- Rectal Neoplasms, Pelvic Neoplasms, Colonic 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 |
|---|---|---|
| Advanced pelvic oncological resection | Complex resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-specific survival
Months
Measured: 10 years
Overall survival
Months
Measured: 10 years
Post-operative complications
Frequency
Measured: 10 years
Quality of life (survey)
Score
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start14 Jan 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Glasgow Royal Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Galbraith, Glasgow Royal Infirmary
- Investigators
- Colin Steele, PhD FRCS, Study director, Glasgow Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696002
- Sponsor's protocol ID
- APSOD
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Pelvic Surgical Oncology Database - Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05696002
- Acronym / sponsor ID
- APSOD
- Conditions
- Rectal Cancer, Pelvic Cancer, Gynecologic Cancer, Colon Cancer
- Keywords
- Pelvic exenteration, Abdominoperineal resection, Reconstructive flap, Rectal cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Glasgow Royal InfirmaryUniversity, hospital or other
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 25 Jan 2023 (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.
Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.
Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.
Detailed description
Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.
Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study..
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced pelvic oncological resection | – | –Complex resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tertiary referral centre
Key inclusion criteria (1 listed)
- Advanced pelvic oncological resection defined as more than 1 pelvic organ resected
Key exclusion criteria (1 listed)
- -
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
Cancer-specific survival
Time frame: 10 years
Months
Overall survival
Time frame: 10 years
Months
Post-operative complications
Time frame: 10 years
Frequency
Quality of life (survey)
Time frame: 10 years
Score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Colin Steele, PhD FRCS study director
Glasgow Royal Infirmary
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 Rectal Cancer and Pelvic Cancer, run by Glasgow Royal Infirmary 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Jan 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norman Galbraith, PhD MRCS (07449784948, norman.galbraith@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-specific survival (time frame: 10 years). The study lists 4 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 25 Jan 2023.