Colorectal CancerNCT04422002
Survival Analysis of Frail Patients With Localised Colorectal Cancer
An observational study of Colorectal Cancer and Surgery, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Surgery, Frailty
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2019to 31 Dec 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: Adults with a recent diagnostic of localised colorectal cancer and a positive frailty screening
Who may be able to join
- Localised colorectal cancer
- Positive frailty screening
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival Analysis of Frail Patients With Localised Colorectal Cancer: Multicentre Observational Study, Comparing Surgical vs Palliative Treatment
The purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment
Read the detailed description
Patients with localized colorectal cancer will be visited by a colorectal surgeon who will explain the disease and the surgical treatment. In this visit the patient will be screened for frailty and asked for informed consent. Patients who meet the eligibility criteria will be sent to the internal medicine consultant to frailty evaluation, risk assessment and counselling in order to help patient decision process.
- Conditions
- Colorectal Cancer, Surgery, Frailty
- Medical subject headings
- Colorectal Neoplasms, Frailty
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 |
|---|---|---|
| Surgical treatment | Not described | |
| Palliative treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 1 year
Secondary outcomes (1)
Surgical complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Dec 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Granados-Maturano, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422002
- Sponsor's protocol ID
- CSPT-ONCOFRAGIL.2020-1
- Status last verified
- Feb 2024
- First submitted
- 2 Jun 2020
- Last updated
- 14 Feb 2024
- 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 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Analysis of Frail Patients With Localised Colorectal Cancer: Multicentre Observational Study, Comparing Surgical vs Palliative Treatment
- ClinicalTrials.gov ID
- NCT04422002
- Acronym / sponsor ID
- CSPT-ONCOFRAGIL.2020-1
- Conditions
- Colorectal Cancer, Surgery, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Jun 2020 (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.
The purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment
Detailed description
Patients with localized colorectal cancer will be visited by a colorectal surgeon who will explain the disease and the surgical treatment. In this visit the patient will be screened for frailty and asked for informed consent. Patients who meet the eligibility criteria will be sent to the internal medicine consultant to frailty evaluation, risk assessment and counselling in order to help patient decision process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | – |
| Palliative treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a recent diagnostic of localised colorectal cancer and a positive frailty screening
Key inclusion criteria (2 listed)
- Localised colorectal cancer
- Positive frailty screening
Key exclusion criteria (1 listed)
- None
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
Survival
Time frame: 1 year
1 secondary outcome
Surgical complications
Time frame: 30 days
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 14 Feb 2024.
- 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. 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 and Surgery, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 14 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 Spain. 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?
Survival (time frame: 1 year). 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 14 Feb 2024.