Colorectal CancerNCT06145230
A Cross-sectional Survey of Colorectal Cancer Patients in Different Age Groups
An observational study of Colorectal Cancer and Age Problem, run by Wang Guiyu at 1 site in China.
Trial summary
This study will help to determine the main clinical symptom differences between patients of different ages, discover the family genetic predisposition of patients of different ages, and obtain the differences in pathological characteristics of patients of different ages, so as to provide help and basis for more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Age Problem
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal cancer patients in different age groups
Who may be able to join
- Adults aged 18 years and older with a pathologic diagnosis of colorectal cancer;
- Undergoing surgical treatment of the primary lesion;
- Voluntary participation of patients.
Who cannot join
- Do not agree to participate in the survey or withdraw informed consent
- Patients did not receive surgical treatment or did not undergo pathologic examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Guiyu Wang, guiywang@163.com
About this study
Official title: A Cross-sectional Survey of Symptomatic Characteristics, Family History and Pathologic Features of Colorectal Cancer Patients in Different Age Groups
This study will help to determine the main clinical symptom differences between patients of different ages, discover the family genetic predisposition of patients of different ages, and obtain the differences in pathological characteristics of patients of different ages, so as to provide help and basis for more accurate and earlier prevention and treatment of colorectal cancer.
Read the detailed description
Colorectal cancer is one of the common and highly prevalent malignant tumors of the gastrointestinal system. Previous studies have found that there may be some differences in disease characteristics and prognosis of colorectal cancer patients at different ages, such as patients with early-onset colorectal cancer (age <50 years) tend to have a worse prognosis than patients with late-onset colorectal cancer (age ≥50 years). However, existing studies on the characteristics of colorectal cancer patients at different ages are not well studied to answer the differences between these patients and develop targeted diagnostic and treatment strategies. Cross-sectional survey research, which uses survey research to collect data on a characteristic group over a certain period of time and statistically analyzes the data to obtain the characteristics of a certain disease or a certain treatment strategy, is a more mature approach that is particularly suitable for the questions that need to be answered in this study. Investigators found that no similar studies have been registered and conducted by searching the official websites of the China Clinical Research Registry and Clinical Trial, and there is a lack of research data on the Chinese population. Therefore, investigators believe there is an urgent need for a cross-sectional survey to study the symptomatic characteristics, family history, and pathologic features of colorectal cancer patients. This study will help to determine the main clinical symptom differences between patients of different ages, discover the family genetic predisposition of patients of different ages, and obtain the differences in pathological characteristics of patients of different ages, so as to provide help and basis for more accurate and earlier prevention and treatment of colorectal cancer.
- Conditions
- Colorectal Cancer, Age Problem
- Keywords
- Colorectal caner, Age group, Family history, Symptomatic characteristics, Pathologic features
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Under 60 group | Colorectal cancer paitents aged under 60 years old ( do not include 60 years old) | |
| 60-69 group | Colorectal cancer paitents aged 60-69 years old | |
| 70-79 group | Colorectal cancer paitents aged 70-79 years old | |
| 80 and over group | Colorectal cancer paitents aged 80 and over 80 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of clinical symptoms
Comparison of the characteristics of clinical symptoms in patients of different ages;
Measured: 2023.12-2024.10
Family history
Comparison of the probability of having a family history in patients of different age stages;
Measured: 2023.12-2024.10
Pathological characteristics
Comparison of pathological characteristics of patients at different age stages;
Measured: 2023.12-2024.10
Secondary outcomes (1)
Risk factors
Analysis of risk factors for stage progression in colorectal cancer patients
Measured: 2024.09-2024.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start12 Dec 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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
- Cross-sectional
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Guiyu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Guiyu, The Second Affiliated Hospital of Harbin Medical University
- Investigators
- Ye Tian, Prof., Study chair, Second Affiliated Hospital of Harbin Medical University Ethics Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145230
- Sponsor's protocol ID
- 2ndHarbinMUSUV
- Status last verified
- Jan 2024
- First submitted
- 9 Oct 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Survey of Symptomatic Characteristics, Family History and Pathologic Features of Colorectal Cancer Patients in Different Age Groups
- ClinicalTrials.gov ID
- NCT06145230
- Acronym / sponsor ID
- 2ndHarbinMUSUV
- Conditions
- Colorectal Cancer, Age Problem
- Keywords
- Colorectal caner, Age group, Family history, Symptomatic characteristics, Pathologic features
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Wang GuiyuUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Nov 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 study will help to determine the main clinical symptom differences between patients of different ages, discover the family genetic predisposition of patients of different ages, and obtain the differences in pathological characteristics of patients of different ages, so as to provide help and basis for more accurate and earlier prevention and treatment of colorectal cancer.
Detailed description
Colorectal cancer is one of the common and highly prevalent malignant tumors of the gastrointestinal system. Previous studies have found that there may be some differences in disease characteristics and prognosis of colorectal cancer patients at different ages, such as patients with early-onset colorectal cancer (age <50 years) tend to have a worse prognosis than patients with late-onset colorectal cancer (age ≥50 years). However, existing studies on the characteristics of colorectal cancer patients at different ages are not well studied to answer the differences between these patients and develop targeted diagnostic and treatment strategies. Cross-sectional survey research, which uses survey research to collect data on a characteristic group over a certain period of time and statistically analyzes the data to obtain the characteristics of a certain disease or a certain treatment strategy, is a more mature approach that is particularly suitable for the questions that need to be answered in this study. Investigators found that no similar studies have been registered and conducted by searching the official websites of the China Clinical Research Registry and Clinical Trial, and there is a lack of research data on the Chinese population. Therefore, investigators believe there is an urgent need for a cross-sectional survey to study the symptomatic characteristics, family history, and pathologic features of colorectal cancer patients. This study will help to determine the main clinical symptom differences between patients of different ages, discover the family genetic predisposition of patients of different ages, and obtain the differences in pathological characteristics of patients of different ages, so as to provide help and basis for more accurate and earlier prevention and treatment of colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Under 60 group | – | –Colorectal cancer paitents aged under 60 years old ( do not include 60 years old) |
| 60-69 group | – | –Colorectal cancer paitents aged 60-69 years old |
| 70-79 group | – | –Colorectal cancer paitents aged 70-79 years old |
| 80 and over group | – | –Colorectal cancer paitents aged 80 and over 80 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients in different age groups
Key inclusion criteria (3 listed)
- Adults aged 18 years and older with a pathologic diagnosis of colorectal cancer;
- Undergoing surgical treatment of the primary lesion;
- Voluntary participation of patients.
Key exclusion criteria (2 listed)
- Do not agree to participate in the survey or withdraw informed consent
- Patients did not receive surgical treatment or did not undergo pathologic examination
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 |
|---|---|---|
| Other | 60-69 group, 70-79 group, 80 and over group, Under 60 group |
Primary outcome
Characteristics of clinical symptoms
Time frame: 2023.12-2024.10
Comparison of the characteristics of clinical symptoms in patients of different ages;
Family history
Time frame: 2023.12-2024.10
Comparison of the probability of having a family history in patients of different age stages;
Pathological characteristics
Time frame: 2023.12-2024.10
Comparison of pathological characteristics of patients at different age stages;
1 secondary outcome
Risk factors
Time frame: 2024.09-2024.10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
Ye Tian, Prof. study chair
Second Affiliated Hospital of Harbin Medical University Ethics Committee
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 Age Problem, run by Wang Guiyu at 1 site in China.
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 5 Jan 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 China. 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 Yuliuming Wang, Dr. (+86-15765191796, wylm3141@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of clinical symptoms (time frame: 2023.12-2024.10). The study lists 3 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 5 Jan 2024.