Clinical trial NCT02863107: Young-Onset Colorectal Cancer
Official title: Young-Onset Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colon Adenocarcinoma
Colorectal Carcinoma
Rectal Adenocarcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 818
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical and epidemiologic data obtained from medical records
timeFrame: Up to 5 years
measure: Identify polymorphism variants and/or new mutations
timeFrame: Up to 5 years
measure: Treatments received including surgical, systemic, and/or radiation treatments
timeFrame: Up to 5 years
measure: Degree of pathologic response to neoadjuvant chemoradiation in patients who received surgical, systemic, and/or radiation treatments
timeFrame: Up to 5 years
measure: Overall response
timeFrame: Up to 5 years
measure: Progression free survival
timeFrame: Up to 3 years
measure: Overall survival
timeFrame: Up to 5 years
measure: Quality of Life in Adult Cancer Survivors (QLACS) scores
timeFrame: Up to 5 years
measure: Adherence score
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Conroe
country: United States
facility: MD Anderson in The Woodlands
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson West Houston
state: Texas
city: League City
country: United States
facility: MD Anderson League City
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson in Sugar Land
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Yi-Qian N You
role: PRINCIPAL_INVESTIGATOR
References: