Young-Onset Colorectal Cancer

N/AActive Not RecruitingNCT02863107

M.D. Anderson Cancer Center818 enrolled

Overview

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.

PRIMARY OBJECTIVES: I. To define the clinical phenotype of young-onset versus (vs.) later onset colorectal cancer (CRC), including clinicopathologic characteristics, tumor molecular markers, family history, and associated lifestyle/environmental factors. II. To examine germline genetic alterations in patients with young-onset (diagnosed between age 18 and 50), CRC and those of their first-degree relatives, in comparison to those in patients with later-onset (diagnosed at age 51 or older) CRC. III. To determine the frequency of the mutations and pattern of inheritance of the mutations identified above in this patient population. IV. To correlate molecular findings to clinical endpoints of survival and disease recurrence and/or progression in patients with young-onset vs. later-onset CRC. V. To compare the treatments received by patients with young-onset vs. later-onset CRC and their subsequent survivorship experiences. OUTLINE: 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). 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.

Study Type

OBSERVATIONAL

Enrollment

818

Conditions

Colon Adenocarcinoma Colorectal Carcinoma Rectal Adenocarcinoma

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood or saliva samples

Medical Chart ReviewOTHER

Review of medical charts

Quality-of-Life AssessmentOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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

Locations (5)

MD Anderson in The Woodlands

Conroe, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

MD Anderson West Houston

Houston, Texas, United States

MD Anderson League City

League City, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.