Colon CancerNCT05388513
Evaluating Factors Affecting Survival in Colon and Rectum Cancer
An observational study of Colon Cancer and Rectum Cancer, run by Umraniye Education and Research Hospital.
Trial summary
Colorectal cancers are frequent among cancers of the gastrointestinal system. Whether there are any differences between survival in rectum and colon cancer patients is controversial. This study aimed to compare survival in the surgically treated rectum and colon cancers and determine the factors affecting survival. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectum Cancer
- What is being tested?
- Surgical Resection
- Type of treatment
- Surgery or procedure
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jan 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients with colon and rectum cancer operated were examined
Who may be able to join
- Patients who were operated and diagnosed histopathologically as adenocarcinoma were included.
Who cannot join
- Inoperable and recurrent colorectal cancer patients and patients that were diagnosed with other than adenocarcinoma were excluded from the study.
About this study
Official title: Evaluating Factors Affecting Survival in Colon and Rectum Cancer: A Prospective Cohort Study With 161 Patients
Colorectal cancers are frequent among cancers of the gastrointestinal system. Whether there are any differences between survival in rectum and colon cancer patients is controversial. This study aimed to compare survival in the surgically treated rectum and colon cancers and determine the factors affecting survival.
Read the detailed description
Colorectal cancers are frequent in the gastrointestinal system. It is the 4th most common cancer after lung, prostate, and bladder in the male population and it is the 3rd after breast and thyroid cancers in the female population according to World Health Organization. It is considered significant morbidity and mortality cause and is estimated to develop in more than 1.000.000 individuals annually worldwide. Colorectal cancers form 10% of all cancers in the female and male populations. It is the 2nd most common cause of death among cancers in the United States of America.
In studies, it is stated that the risk of developing colorectal cancer in an individual is 5-6%. Also, the risk of death of an individual due to colorectal cancer was determined as 3%. In the last 50 years, the rate of colorectal cancer mortality decreased in the female population while it did not change in the male population. Whether there is a difference in survival time between rectum and colon cancers is controversial.
With the development in neoadjuvant treatment approaches, poor prognosis in past years got better. Recent studies show that the prognosis in rectum cancers is better than in colon. Nevertheless, factors affecting prognosis other than treatment for both colon and rectum cancers are not clarified.
In this study, the investigators aimed to evaluate the surgically treated rectum and colon cancer patients' survival and factors affecting survival time.
- Conditions
- Colon Cancer, Rectum Cancer
- Being tested
- Surgical Resection
- Keywords
- Survival, Prognostic factors
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ResectionProcedure or surgery
Surgically treated patients included
| Study group | Role | What they receive |
|---|---|---|
| Colon | The patients who are operated with colon cancer Receives: Procedure: Surgical Resection | |
| Rectum | The patients who are operated with rectum cancer Receives: Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
5 year survival data is used.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study startJan 2009
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatih Basak, Umraniye Education and Research Hospital
- Investigators
- Fatih Başak, Principal investigator, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388513
- Sponsor's protocol ID
- ColoRectalCancers
- Status last verified
- May 2022
- First submitted
- 7 Sep 2016
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Factors Affecting Survival in Colon and Rectum Cancer: A Prospective Cohort Study With 161 Patients
- ClinicalTrials.gov ID
- NCT05388513
- Acronym / sponsor ID
- ColoRectalCancers
- Conditions
- Colon Cancer, Rectum Cancer
- Keywords
- Survival, Prognostic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 May 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.
Colorectal cancers are frequent among cancers of the gastrointestinal system. Whether there are any differences between survival in rectum and colon cancer patients is controversial. This study aimed to compare survival in the surgically treated rectum and colon cancers and determine the factors affecting survival.
Detailed description
Colorectal cancers are frequent in the gastrointestinal system. It is the 4th most common cancer after lung, prostate, and bladder in the male population and it is the 3rd after breast and thyroid cancers in the female population according to World Health Organization. It is considered significant morbidity and mortality cause and is estimated to develop in more than 1.000.000 individuals annually worldwide. Colorectal cancers form 10% of all cancers in the female and male populations. It is the 2nd most common cause of death among cancers in the United States of America.
In studies, it is stated that the risk of developing colorectal cancer in an individual is 5-6%. Also, the risk of death of an individual due to colorectal cancer was determined as 3%. In the last 50 years, the rate of colorectal cancer mortality decreased in the female population while it did not change in the male population. Whether there is a difference in survival time between rectum and colon cancers is controversial.
With the development in neoadjuvant treatment approaches, poor prognosis in past years got better. Recent studies show that the prognosis in rectum cancers is better than in colon. Nevertheless, factors affecting prognosis other than treatment for both colon and rectum cancers are not clarified.
In this study, the investigators aimed to evaluate the surgically treated rectum and colon cancer patients' survival and factors affecting survival time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colon | – | Procedure: Surgical ResectionThe patients who are operated with colon cancer |
| Rectum | – | Procedure: Surgical ResectionThe patients who are operated with rectum cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with colon and rectum cancer operated were examined
Key inclusion criteria (1 listed)
- Patients who were operated and diagnosed histopathologically as adenocarcinoma were included.
Key exclusion criteria (1 listed)
- Inoperable and recurrent colorectal cancer patients and patients that were diagnosed with other than adenocarcinoma were excluded from 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ResectionSurgically treated patients included | Procedure or surgery | Colon, Rectum |
Primary outcome
Survival
Time frame: 5 year
5 year survival data is used.
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 24 May 2022.
- Individual participant dataSharing planned: No
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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.
Fatih Başak principal investigator
Umraniye Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Rectum Cancer, run by Umraniye Education and Research Hospital.
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: finished, as of the sponsor's last update on 24 May 2022. 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?
Survival (time frame: 5 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 24 May 2022.