- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02863107
Young-Onset Colorectal Cancer
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Conroe, Texas, United States, 77384
- MD Anderson in The Woodlands
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
Houston, Texas, United States, 77079
- MD Anderson West Houston
-
League City, Texas, United States, 77573
- MD Anderson League City
-
Sugar Land, Texas, United States, 77478
- MD Anderson in Sugar Land
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
Ancillary studies
Other Names:
Complete questionnaires
Review of medical charts
Other Names:
Undergo collection of blood or saliva samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
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.
|
Up to 3 years
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yi-Qian N You, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenocarcinoma
- Colonic Neoplasms
Other Study ID Numbers
- PA11-0566 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-07462 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Colorectal Carcinoma
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Recurrent Colorectal Carcinoma | Metastatic Colorectal Carcinoma | Refractory Colorectal CarcinomaUnited States
-
Roswell Park Cancer InstituteNot yet recruitingPembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)Recurrent Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Unresectable Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal CarcinomaUnited States
-
Wuhan Union Hospital, ChinaNot yet recruitingRecurrent Colorectal Carcinoma | Advanced Colorectal CarcinomaChina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Carcinoma | Colorectal Adenoma and CarcinomaNetherlands
-
Mayo ClinicCompletedMetastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Metastatic... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Center for Advancing Translational Sciences (NCATS)Not yet recruitingRecurrent Colorectal Carcinoma | Locally Advanced Colorectal Carcinoma | Stage III Colorectal CancerUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)Not yet recruitingMetastatic Malignant Neoplasm in the Liver | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Unresectable Colorectal Carcinoma
-
National Cancer Institute (NCI)RecruitingUnresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Unresectable Colorectal CarcinomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingMetastatic Colorectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Metastatic Microsatellite Stable Colorectal Carcinoma | Advanced Microsatellite Stable Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
Clinical Trials on Quality-of-Life Assessment
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Malignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingChildhood Malignant NeoplasmUnited States, Canada, Puerto Rico, Australia, New Zealand
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
-
M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Breast Carcinoma | Head and Neck Carcinoma | Lung Carcinoma | Esophageal Carcinoma | Malignant Digestive System Neoplasm | Malignant Central Nervous System Neoplasm | Genitourinary System CarcinomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBreast Carcinoma | Cancer SurvivorUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedFallopian Tube Cancer | Recurrent Endometrial Carcinoma | Stage IV Ovarian Epithelial Cancer | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Recurrent Uterine Sarcoma | Stage III Uterine Sarcoma | Stage IV Uterine Sarcoma | Recurrent Ovarian Epithelial Cancer | Stage IV Endometrial Carcinoma | Ovarian... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States