Rectal NeoplasmsNCT05475301
Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer
An observational study of Rectal Neoplasms and Neoplasm Recurrence, Local, run by Radboud University Medical Center.
Trial summary
Data on disease recurrence was collected for all primary rectal cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locally recurrent rectal cancer were determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms, Neoplasm Recurrence, Local
- How many people
- 1,431 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 2015
- How long will I take part?
- 6 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: All patients diagnosed with stage I-III primary rectal cancer in the first half of 2015.
Who may be able to join
- Histologically confirmed stage I-III primary rectal carcinoma;
- Diagnosed between January 1st and June 30th of 2015;
- TME resection of primary rectal carcinoma.
Who cannot join
- Neuroendocrine tumor morphology;
About this study
Official title: Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer: a Retrospective, Population-based Cohort Study
Data on disease recurrence was collected for all primary rectal cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locally recurrent rectal cancer were determined.
- Conditions
- Rectal Neoplasms, Neoplasm Recurrence, Local
- Medical subject headings
- Rectal Neoplasms, Neoplasm Recurrence, Local
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients
UNIT OF MEASUREMENT: Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients MEASUREMENT TOOL: Registration of diagnosis of locally recurrent rectal cancer in the electronic patient file.
The competing-risk cumulative incidence will be calculated, which will inform on the proportion of patients who have developed locally recurrent rectal cancer at that time point.
Measured: Three years
Risk factors for development of locally recurrent rectal cancer in curatively treated primary rectal cancer patients
UNIT OF MEASUREMENT: Risk factors for development of locally recurrent rectal cancer in primary rectal cancer patients MEASUREMENT TOOL: Registration of clinical and pathological covariates of primary rectal cancer in the electronic patient file and national pathological database (PALGA).
Clinical and pathological risk factors for the development of locally recurrent rectal cancer will be identified using multivariable competing-risk risk regression analyses, according to the cause-specific hazard approach. This will inform on specific clinical and pathological covariates which increase or decrease the risk for development of locally recurrent rectal cancer.
Measured: Three years
Proportions of treatment given to patients with locally recurrent rectal cancer
UNIT OF MEASUREMENT: Proportions of treatment given to patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of treatment for locally recurrent rectal cancer in the electronic patient file.
Using descriptive statistics, treatment patterns of patients with locally recurrent rectal cancer will be identified. Groups that will be created, will also be used to assess overall survival.
Measured: Three years
Overall survival of patients with locally recurrent rectal cancer
UNIT OF MEASUREMENT: Overall survival of patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of vital status in the national personal records database.
Overall survival will be estimated for patients with locally recurrent rectal cancer, stratifying for different groups (i.e. treatment, diagnosis of synchronous metastases, diagnosis within first year after primary resection, etc.)
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2015
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 1,431 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hidde Swartjes, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475301
- Sponsor's protocol ID
- K20.256
- Status last verified
- Nov 2023
- First submitted
- 15 Jul 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be requested through the Netherlands Cancer Registry.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer: a Retrospective, Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT05475301
- Acronym / sponsor ID
- K20.256
- Conditions
- Rectal Neoplasms, Neoplasm Recurrence, Local
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,431 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 26 Jul 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.
Data on disease recurrence was collected for all primary rectal cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locally recurrent rectal cancer were determined.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with stage I-III primary rectal cancer in the first half of 2015.
Key inclusion criteria (3 listed)
- Histologically confirmed stage I-III primary rectal carcinoma;
- Diagnosed between January 1st and June 30th of 2015;
- TME resection of primary rectal carcinoma.
Key exclusion criteria (1 listed)
- Neuroendocrine tumor morphology;
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
Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients
Time frame: Three years
UNIT OF MEASUREMENT: Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients MEASUREMENT TOOL: Registration of diagnosis of locally recurrent rectal cancer in the electronic patient file. The competing-risk cumulative incidence will be calculated, which will inform on the proportion of patients who have developed locally recurrent rectal cancer at that time point.
Risk factors for development of locally recurrent rectal cancer in curatively treated primary rectal cancer patients
Time frame: Three years
UNIT OF MEASUREMENT: Risk factors for development of locally recurrent rectal cancer in primary rectal cancer patients MEASUREMENT TOOL: Registration of clinical and pathological covariates of primary rectal cancer in the electronic patient file and national pathological database (PALGA). Clinical and pathological risk factors for the development of locally recurrent rectal cancer will be identified using multivariable competing-risk risk regression analyses, according to the cause-specific hazard approach. This will inform on specific clinical and pathological covariates which increase or decrease the risk for development of locally recurrent rectal cancer.
Proportions of treatment given to patients with locally recurrent rectal cancer
Time frame: Three years
UNIT OF MEASUREMENT: Proportions of treatment given to patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of treatment for locally recurrent rectal cancer in the electronic patient file. Using descriptive statistics, treatment patterns of patients with locally recurrent rectal cancer will be identified. Groups that will be created, will also be used to assess overall survival.
Overall survival of patients with locally recurrent rectal cancer
Time frame: Three years
UNIT OF MEASUREMENT: Overall survival of patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of vital status in the national personal records database. Overall survival will be estimated for patients with locally recurrent rectal cancer, stratifying for different groups (i.e. treatment, diagnosis of synchronous metastases, diagnosis within first year after primary resection, etc.)
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 18 Nov 2023.
- Individual participant dataSharing planned: No. Data can be requested through the Netherlands Cancer Registry.
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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 Rectal Neoplasms and Neoplasm Recurrence, Local, run by Radboud University Medical Center.
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 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 18 Nov 2023. 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?
Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients (time frame: Three 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 18 Nov 2023.