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OpenTrials
Active, Not Recruiting

NCT Number: NCT02863107

Young-Onset Colorectal Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Colon Adenocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Adenocarcinoma Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MD Anderson in The Woodlands, Conroe, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood or saliva samples

medical chart review

Other

Review of medical charts

Other names: Chart Review

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Clinical and epidemiologic data obtained from medical records

    Time frame: Up to 5 years

    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.

  2. Identify polymorphism variants and/or new mutations

    Time frame: Up to 5 years

    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.

  3. Treatments received including surgical, systemic, and/or radiation treatments

    Time frame: Up to 5 years

    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.

  4. Degree of pathologic response to neoadjuvant chemoradiation in patients who received surgical, systemic, and/or radiation treatments

    Time frame: Up to 5 years

    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.

  5. Overall response

    Time frame: Up to 5 years

    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.

  6. Progression free survival

    Time frame: Up to 3 years

    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.

  7. Overall survival

    Time frame: Up to 5 years

    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.

  8. Quality of Life in Adult Cancer Survivors (QLACS) scores

    Time frame: Up to 5 years

    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.

  9. Adherence score

    Time frame: Up to 5 years

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2030
Study completion
2030
First posted
Aug 11, 2016
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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