Longitudinal Study of Symptoms in Colorectal Cancer | NCT00777192

Studies
Longitudinal Study of Symptoms in Colorectal Cancer

NCT00777192

Sponsor

M.D. Anderson Cancer Center

Status

Terminated

Last Update Posted

May 29, 2019Actual

Enrollment

509Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Questionnaires

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated at continuing review

Expanded Access Info

Start Date

Aug 2008Actual

Primary Completion Date

Dec 27, 2018Actual

Completion Date

Dec 27, 2018Actual

First Submitted Date

Oct 20, 2008

First Submission Date that Met QC Criteria

Oct 20, 2008

First Posted Date

Oct 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2019

Last Update Posted Date

May 29, 2019Actual

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.

Detailed Description

If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled visit. The questionnaires are designed to measure pain and other symptoms, your mood, and your quality of life.

You will also give a tissue sample by inserting a cotton tipped swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about 1 minute at the most.

Completing the 5 questionnaires and the swab sample should take about 30 minutes.

Length of Study:

After you complete the questionnaires and the swab sample collection, your active participation in this study will be over.

This is an investigational study.

Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

509Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Symptoms in Colorectal Cancer		Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy	Behavioral: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Behavioral	20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life	Symptoms in Colorectal Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients		5 Years

Secondary Outcomes

Measure	Description	Time Frame
Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time		5 Years
Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients		Neuropsychological test battery at baseline and 3 + 6 month follow ups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with colorectal cancer meeting one of the following criteria: 1. naive to oxaliplatin or to any microtubule stabilizing agents (e.g. Taxol, Abraxane, Ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal study cohort 1); or 2. during first 5 years from colorectal cancer diagnosis (cross-sectional study cohort). This second cohort may include patients with colorectal cancer from the original 12-month study (the longitudinal cohort), both those who completed the study and those who dropped out. It may also include new patients who did not participate in the longitudinal phase of the study.
Patients >= 18 years old.
Patients who speak English or Spanish.

Exclusion Criteria:

Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's Common Terminology Criteria (CTCv3.0).
Patients who do not understand the intent of the study.
Cohort 1 patients unable to use the interactive voice response (IVR) system due to physical limitations (e.g., hearing impairment).
Cohort 1 patients with a history of inflammatory bowel disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients having oxaliplatin chemotherapy as a treatment for colorectal cancer.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xin Shelley Wang, MD. MPH	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas MD Anderson Cancer Center		Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26882477	Derived	Wang XS, Shi Q, Dougherty PM, Eng C, Mendoza TR, Williams LA, Fogelman DR, Cleeland CS. Prechemotherapy Touch Sensation Deficits Predict Oxaliplatin-Induced Neuropathy in Patients with Colorectal Cancer. Oncology. 2016;90(3):127-35. doi: 10.1159/000443377. Epub 2016 Feb 17.

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms