A Cross-sectional Survey of Colorectal Cancer Patients in Different Age Groups

January 4, 2024 updated by: Wang Guiyu

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yuliuming Wang, Dr.
  • Phone Number: +86-15765191796
  • Email: wylm3141@163.com

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • Recruiting
        • The 2nd Affiliated Hospital of Harbin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Colorectal cancer patients in different age groups

Description

Inclusion Criteria:

  1. Adults aged 18 years and older with a pathologic diagnosis of colorectal cancer;
  2. Undergoing surgical treatment of the primary lesion;
  3. Voluntary participation of patients.

Exclusion Criteria:

  1. Do not agree to participate in the survey or withdraw informed consent
  2. Patients did not receive surgical treatment or did not undergo pathologic examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Characteristics of clinical symptoms
Time Frame: 2023.12-2024.10
Comparison of the characteristics of clinical symptoms in patients of different ages;
2023.12-2024.10
Family history
Time Frame: 2023.12-2024.10
Comparison of the probability of having a family history in patients of different age stages;
2023.12-2024.10
Pathological characteristics
Time Frame: 2023.12-2024.10
Comparison of pathological characteristics of patients at different age stages;
2023.12-2024.10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk factors
Time Frame: 2024.09-2024.10
Analysis of risk factors for stage progression in colorectal cancer patients
2024.09-2024.10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wang Guiyu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ye Tian, Prof., Second Affiliated Hospital of Harbin Medical University Ethics Committee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2ndHarbinMUSUV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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