Advanced Colorectal Cancer in Elderly PatientCO-OLDERNCT05788224
The Management of Complicated Colo-rectal Cancer in Older Patients in the Emergency Setting: the CO-OLDER Study
An observational study of Advanced Colorectal Cancer in Elderly Patient, run by Poissy-Saint Germain Hospital at 1 site in France.
Trial summary
This is a multicenter observational study aimed to investigate the management of older patients aged 75 years old and over admitted to the emergency department with complicated colorectal cancer. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Advanced Colorectal Cancer in Elderly Patient
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 2 Jan 2024
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All older (aged 75 years old and over) patients who were admitted to the surgical department with acute abdominal pain due to a complication of colorectal cancer.
Who may be able to join
- Patients aged 75 years old and over;
- Admission to the emergency department with acute abdominal pain;
- Diagnosis of obstructed and/or perforated colorectal cancer.
Who cannot join
- Patients aged< 75 years old;
- Patients aged >=75 years old admitted with acute abdomen, not due to complicated colorectal cancer.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
World Society of Emergency Surgery
Paris, 75016
Belinda De Simone, MD, +33665787872, desimone.belinda@gmail.com
Belinda De Simone, MD
About this study
This is a multicenter observational study aimed to investigate the management of older patients aged 75 years old and over admitted to the emergency department with complicated colorectal cancer.
The final endpoint is to report morbidity and mortality in this group of frail individuals according to the shift of incidence of colorectal cancer in geriatric patients, over 2 periods: before the COVID pandemic outbreak (11th March 2020) and after the 11th March, during the ongoing pandemic.
- Keywords
- elderly; oldest; colorectal cancer; perforation; bleeding; obstruction; emergency; surgery; laparotomy; laparoscopy; futility; frailty
- Medical subject headings
- Colorectal Neoplasms, Hemorrhage, Bites and Stings, Emergencies, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality and morbidity correlated with the management of older (=>75 years old) patients admitted to emergency department with a complicated colorectal cancer
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 May 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion2 Jan 2024 (estimated)
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 Advanced Colorectal Cancer in Elderly PatientStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fausto Catena, World Society of Emergency Surgery
- Responsible party
- Principal investigator, Belinda De Simone, World Society of Emergency Surgery
- Investigators
- Belinda De Simone, MD, Principal investigator, World Society of Emergency Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788224
- Sponsor's protocol ID
- BDS02
- Acronym
- CO-OLDER
- Status last verified
- May 2023
- First submitted
- 14 Mar 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
DE Simone B, Abu-Zidan FM, Podda M, Pellino G, Sartelli M, Coccolini F, DI Saverio S, Biffl WL, Kaafarani HM, Moore EE, Dhesi JK, Moug S, Ansaloni L, Avenia N, Catena F; CO-OLDER Collaborators. The management of complicated colorectal cancer in older patients in a global perspective after COVID-19: the CO-OLDER WSES project. Minerva Surg. 2024 Jun;79(3):273-285. doi: 10.23736/S2724-5691.23.10165-1.
PubMed 38847766
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Complicated Colo-rectal Cancer in Older Patients in the Emergency Setting: the CO-OLDER Study
- ClinicalTrials.gov ID
- NCT05788224
- Acronym / sponsor ID
- CO-OLDER / BDS02
- Keywords
- elderly; oldest; colorectal cancer; perforation; bleeding; obstruction; emergency; surgery; laparotomy; laparoscopy; futility; frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Collaborators
- Fausto Catena, World Society of Emergency Surgery
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 2 Jan 2024 (estimated)
- First posted
- 28 Mar 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.
This is a multicenter observational study aimed to investigate the management of older patients aged 75 years old and over admitted to the emergency department with complicated colorectal cancer.
The final endpoint is to report morbidity and mortality in this group of frail individuals according to the shift of incidence of colorectal cancer in geriatric patients, over 2 periods: before the COVID pandemic outbreak (11th March 2020) and after the 11th March, during the ongoing pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All older (aged 75 years old and over) patients who were admitted to the surgical department with acute abdominal pain due to a complication of colorectal cancer.
Key inclusion criteria (3 listed)
- Patients aged 75 years old and over;
- Admission to the emergency department with acute abdominal pain;
- Diagnosis of obstructed and/or perforated colorectal cancer.
Key exclusion criteria (2 listed)
- Patients aged< 75 years old;
- Patients aged >=75 years old admitted with acute abdomen, not due to complicated colorectal cancer.
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
mortality and morbidity correlated with the management of older (=>75 years old) patients admitted to emergency department with a complicated colorectal cancer
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 38847766DE Simone B, Abu-Zidan FM, Podda M, Pellino G, Sartelli M, Coccolini F, DI Saverio S, Biffl WL, Kaafarani HM, Moore EE, Dhesi JK, Moug S, Ansaloni L, Avenia N, Catena F; CO-OLDER Collaborators. The management of complicated colorectal cancer in older patients in a global perspective after COVID-19: the CO-OLDER WSES project. Minerva Surg. 2024 Jun;79(3):273-285. doi: 10.23736/S2724-5691.23.10165-1.
Related trials for Advanced Colorectal Cancer in Elderly Patient
Not yet recruitingPhase 2
Clinical Efficacy of Transarterial Chemoembolization in Elderly Patients With Advanced Unresectable Colorectal Cancer
Unresectable Colorectal Cancer, Advanced Malignancy
RecruitingPhase 2
Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in Elderly Patients as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer.
Colorectal Cancer
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.
Belinda De Simone, MD principal investigator
World Society of Emergency Surgery
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 Advanced Colorectal Cancer in Elderly Patient, run by Poissy-Saint Germain Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 24 May 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 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 Belinda De Simone, MD (+33665787872, desimone.belinda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality and morbidity correlated with the management of older (=>75 years old) patients admitted to emergency department with a complicated colorectal cancer (time frame: through study completion, an average of 1 year). 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 NCT05788224, 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 24 May 2023.