Young-Onset Colorectal Cancer
2 other identifiers
observational
818
1 country
5
Brief Summary
This study investigates the genetic factors that may influence the risk of developing colorectal cancer at a young age. Finding genetic markers for colorectal may help identify patients who are at risk of colorectal cancer. Studying individuals and families at high risk of cancer may help identify cancer genes and other persons at risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2012
CompletedFirst Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2030
April 16, 2026
April 1, 2026
18.2 years
August 8, 2016
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (9)
Clinical and epidemiologic data obtained from medical records
Including age of colorectal cancer (CRC) diagnosis, gender, race/ethnicity, insurance status, tumor-related variables including location of the CRC, clinical and pathologic stage of CRC, histologic features including histologic grade of differentiation, mucinous histology, signet ring, and adverse features such as lymphovasucalar invasion and perineural invasion, as well as information provided from patients regarding their family history and their dietary, environmental and lifestyle information will be described using descriptive statistics. All continuous variables were described as median and interquartile range, and categorical variables as number and percentage. Comparisons between the young and the older cohorts were performed by using the Wilcoxon rank-sum test for continuous variables and Chi-squared or Fisher's exact tests for categorical variables as appropriate.
Up to 5 years
Identify polymorphism variants and/or new mutations
Will use bioinformatic analysis to analyze and understand the identified polymorphism variants and/or new mutations. Chi-squared test will be used to test for differences between the young-onset versus (vs.) later-onset cohorts for each polymorphism variant or mutation genotype, with odds ratio and 95% confidence intervals as estimates of relative risk. A tree-based statistical approach using classification and regression tree analysis segregating study versus reference cohorts will be used. Genotypes will be coded and analyzed for the additive, dominant, recessive, or codominant models.
Up to 5 years
Treatments received including surgical, systemic, and/or radiation treatments
Will be compared between the young and the older cohorts by using the Wilcoxon rank-sum test for continuous variables and Chi-squared or Fisher's exact tests for categorical variables as appropriate.
Up to 5 years
Degree of pathologic response to neoadjuvant chemoradiation in patients who received surgical, systemic, and/or radiation treatments
Will be compared between the young and the older cohorts by using the Wilcoxon rank-sum test for continuous variables and Chi-squared or Fisher's exact tests for categorical variables as appropriate.
Up to 5 years
Overall response
Will be compared between the young and the older cohorts by using the Wilcoxon rank-sum test for continuous variables and Chi-squared or Fisher's exact tests for categorical variables as appropriate.
Up to 5 years
Progression free survival
Will be calculated. Will use Kaplan-Meier analysis to characterize the shapes of the survival curves according to normal or variant genotypes and Cox proportional hazards modeling to evaluate the association of variant genotypes, allowing for covariates such as age and stage that may vary according to genotypes and need to be controlled for evaluate evidence for an independent effect of genotype on survival or time to relapse.
Up to 3 years
Overall survival
Will be calculated. Will use Kaplan-Meier analysis to characterize the shapes of the survival curves according to normal or variant genotypes and Cox proportional hazards modeling to evaluate the association of variant genotypes, allowing for covariates such as age and stage that may vary according to genotypes and need to be controlled for evaluate evidence for an independent effect of genotype on survival or time to relapse.
Up to 5 years
Quality of Life in Adult Cancer Survivors (QLACS) scores
Standard scoring menu for the QLACS will be followed to obtain domain and overall scores for the QLACS. Scores will be compared between the young and older cohorts using Wilcoxon rank sum test, and the p-values will be adjusted for multiple comparisons. Mixed effects models will be constructed to analyze changes over time. In secondary analyses, quality of life scores will be stratified by disease stage, site and status. Responder bias will be assessed by comparing responders vs. non-responders for patient-, disease-, and treatment-related factors.
Up to 5 years
Adherence score
For the survivorship care questionnaire, a summation "adherence score" will be calculated for each patient in terms of whether guideline recommended survivorship care was received by the patient. The "adherence scores" will be compared between the young vs. older cohorts using Wilcoxon rank sum test.
Up to 5 years
Study Arms (1)
Observational (questionnaire, biospecimen collection)
PATIENTS: Patients complete questionnaires over 30-50 minutes about work, family history, medical history, health habits, and experience as a cancer survivor (quality of life, well-being, concerns, types of health care, and follow-up care received). Patients also undergo collection of blood or saliva samples. Active patients, who have undergone treatment at MD Anderson Cancer Center within the past year, complete additional questionnaires at enrollment, 6 months, 12 months after treatment completion, and then every years for up to 6 years. Also, active patients who are consented to the study more than 5 years from surgery, they may complete the survivorship questionnaire once. Patients medical records are also reviewed. FAMILY MEMBERS: Participants complete questionnaires over 10-15 minutes. Participants also undergo collection of blood or saliva samples once.
Interventions
Undergo collection of blood or saliva samples
Review of medical charts
Ancillary studies
Complete questionnaires
Eligibility Criteria
MD Anderson Cancer Center (MDACC) patients who have adenocarcinoma of the colon or rectum, diagnosed between ages 18 through 50 (young-onset), or diagnosed at age 51 through 80 (later-onset) and their family members
You may qualify if:
- PATIENTS: MDACC patients who have adenocarcinoma of the colon or rectum, diagnosed between ages 18 through 50 (young-onset), or diagnosed at age 51 through 80 (later-onset)
- PATIENTS: Patient must have sufficient command of the English language and mental capacity to provide consent
- FAMILY MEMBERS: Be a parent, sibling or child (first degree blood relative) of a registered MDACC patient meeting eligibility criteria above
- FAMILY MEMBERS: Have sufficient command of the English language and mental capacity to provide consent
- FAMILY MEMBERS: Family member must be at least 18 years of age at the time of study registration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
MD Anderson League City
League City, Texas, 77573, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
Related Links
Biospecimen
Blood, saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Qian N You
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2016
First Posted
August 11, 2016
Study Start
June 7, 2012
Primary Completion (Estimated)
August 31, 2030
Study Completion (Estimated)
August 31, 2030
Last Updated
April 16, 2026
Record last verified: 2026-04